MD - Medical Devices-10

5/19/23, 5:59 PM MD - Medical Devices
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No.  License Number  Holder Name  Device Name(Brand Name)-Intended Use  Authority  Class 
901 IMP/IVD/2020/000310 LifeCell In vitro polymerase chain reaction (PCR) assay for CDSCO Class C
International Private CO V I D 19(GeneFinderTM COVID-19 Plus
Limited RealAmp Kit)-This kit based on the r everse
Transcription and Real Time Polymerase Chain
Reaction from RNA extracted from Respiratory
specimens such as Alveolar lavage fluid, throat
swab, sputum. This product can qualitatively
detect COVID 19 using Reaction
https://cdscomdonline.gov.in/NewMedDev/ListOfApprovedDevices 1/122

902 IMP/IVD/2020/000311 M/s Aracion 2019-nCoV Ab Test (Colloidal Gold)(--)- The kit is CDSCO Class C
Technology Private intended for the qualitative detection of IgM and
Limited IgG antibodies against 2019 Novel Coronavirus
(2019-nCoV) in human serum/plasma/venous
whole blood specimen. It is only used as a
supplementary detection indicator for suspected
nucleic acid negative results or in conjunction with
nucleic acid detection in the diagnosis of
suspected cases. It cannot be used as a basis for
the diagnosis and exclusion of COVID-19. It is not
suitable for general screening. A positive test result
requires further confirmation. A negative test result
does not rule out the possibility of infection. This
product is limited to clinical use and emergency
reserve during the COVID-19 epidemic outbreak
since December 2019, and cannot be used in the
clinic as a conventional in vitro diagnostic reagent.
The test results of this kit are for clinical reference
only. It is recommended to conduct a
comprehensive analysis of the condition based on
the patient's clinical manifestations and other
laboratory tests.

903 IMP/IVD/2020/000314 Meridian Medicare Covid-19 IgM(GEN BODY)-GenBody Covid-19 CDSCO Class C
Ltd. IgM device is a chromaticgraphic immunoassay Kit
for the rapid and differential detection of
immunoglobulin M (IgM)against Covid-19 using
Serum, Plasma & whole Blood. ,Covid-19
IgG(GEN BODY)-GenBody Covid-19 IgG device is
a chromaticgraphic immunoassay Kit for the rapid
and differential detection of immunoglobulin G
(IgG)against Covid-19 using Serum, Plasma &
whole Blood.,Covid-19 Assay Solution(GEN
BODY)-GenBody Covid-19 IgM/IgG device is a
chromaticgraphic immunoassay Kit for the rapid
and differential detection of immunoglobulin M & G
(IgM & IgG)against Covid-19 using Serum, Plasma
& whole Blood.
904 IMP/IVD/2020/000315 DEEP MEDITECH Urine Analyzer-For qualitative and/or quantitative CDSCO Class A
PVT. LTD. in vitro determination of various chemical and
cellular constituents of a clinical urine
specimen.,Hemoglobin Testing System(Mission)-
To determine the concentration of hemoglobin in a
clinical specimen.,NES-32 Nucleic Acid Extraction
System-For the pre-analytical preparation of
samples for downstream nucleic acid
analysis.,Cholesterol Monitoring System(Mission)-
For the quantitative in vitro determination of lipid
profile analytes in a clinical specimen.

905 IMP/IVD/2020/000315 DEEP MEDITECH Cholesterol Test Devices-For estimation of Total CDSCO Class B
PVT. LTD. Cholesterol, HDL and Triglycerides,CHOL Total
Cholesterol Test Strips-For estimation of
Cholesterol,Hb Haemoglobin Test Strips-For
estimation of Hemoglobin,Liquid Urine Control-For
quality control of urine analysis reagent
strips,Urine Analysis Reagent Strips-For estimation
of Glucose, Bilirubin, pH, Specific Gravity, Protein,
Urobilinogen, Nitrite, Ketone, Blood, Leukocyte,
Ascorbic Acid, Microalbumin, Creatinine, Calcium
etc. in urine

906 IMP/IVD/2020/000315 DEEP MEDITECH Whole Blood Genomic DNA Extraction Kit CDSCO Class C
PVT. LTD. (Magnetic Beads)-Kit for DNA extraction from
whole blood specimens using magnetic beads
method.,Nucleic Acid (DNA) Extraction Kit
(Magnetic Beads)-Kit for extraction of DNA from
various specimens, such as serum, plasma, swab,
feces and urine.,Nucleic Acid (RNA) Extraction Kit
(Magnetic Beads)-Kit for extraction of RNA from
various specimens, such as serum, plasma, swab
and feces.,Viral Nucleic Acid Isolation Kit-Viral
Nucleic Acid Isolation Kit is designed for rapid
isolation and purification of nucleic acids from
serum, plasma or swab.,Promotor Nucleic Acid
Extraction Kit(Promotor)-The Promotor® Nucleic
Acid Extraction Kit is designed to be used with the
Promotor® N ES-32 Nucleic Acid Extraction
System for extracting DNA or RNA from various
specimens, such as serum, plasma, swab,
sputum. Extracted nucleic acid can be used in
biological applications and clinical molecular
diagnostics, such as, nucleic acid testing, gene
cloning and sequencing, PCR, molecular
hybridization, etc.,SARS-CoV-2 Antigen Rapid
Test(Flowflex)-A rapid test for the qualitative
detection of SARS-CoV-2 nucleocapsid antigens in
nasal and nasopharyngeal swab specimens.

907 IMP/IVD/2020/000317 Aadivighnesh Real-Time PCR Coronavirus (SARS-CoV-2) CDSCO Class C

Chem. Pvt. Ltd., Detection Test(Quanti Virus™)-The QuantiVirus™
Real-Time RT- PCR Coronavirus (SARS-CoV-2)
Detection Test is a real-time reverse transcription
(RT)-PCR in vitro diagnostic test intended for the
qualitative detection of viral nucleic acid from the
SARS-CoV-2 in respiratory specimens from
individuals. The QuantiVirus™ kit is to be used by
trained laboratory professionals for the detection of
SARS-CoV-2 viral RNA.
908 IMP/IVD/2020/000318 TARA MEDICOS qSARS-CoV-2 IgG/IgM Cassette Rapid Test(Cellex CDSCO Class D
PRIVATE LIMITED qSARS-CoV-2 IgG/IgM Cassette Rapid Test)-The
Cellex qSARS-CoV-2 IgG/IgM Cassette Rapid Test
is a lateral flow immunoassay for the qualitative
detection of 2019-nCoV IgM/IgG antibodies in
serum, plasma or whole blood specimens. It is
intended to be used as a screening test and aid in
the diagnosis of SARS-CoV-2 viral infections. Any
reactive specimen with the Cellex qSARS-CoV-2
IgG/IgM Cassette Rapid Test must be confirmed
with alternative testing method(s).

909 IMP/IVD/2020/000320 HUMOLE Allplex 2019-nCoV Assay(Allplex)-Allplex 2019- CDSCO Class C

DIAGNOSTICS nCoV Assay is in vitro diagnostic medical device
PRIVATE LIMITED designed for qualitative detection of novel Corona
virus (2019-nCoV) with real-time reverse
transcription PCR from sputum, nasopharyngeal
aspirate, oropharyngeal (throat) & nasopharyngeal
swab, and bronchoalveolar lavage.,SARS-CoV-2
Master Assay(Allplex™)-Allplex™ SARS-CoV-2
Master Assay is in vitro diagnostic medical device
designed for qualitative detection of SARS-CoV-2
and variants of S gene (HV69/70del, Y144del,
E484K, N501Y, P681H) with real-time reverse
transcription PCR from nasopharyngeal aspirate,
nasopharyngeal swab, bronchoalveolar lavage,
oropharyngeal (throat) swab, sputum, and saliva.
910 IMP/IVD/2020/000321 Instrumentation HemosIL AcuStar Triggers(HemosIL)-Catalyst and CDSCO Class B

Laboratory India Pvt oxidizer solutions for triggering chemiluminescent
Ltd reaction on the ACL AcuStar systems.,HemosIL
AcuStar Cleaning solution(HemosIL)-Cleaning
solution for use on the ACL AcuStar
systems,HemosIL AcuStar System
Rinse(HemosIL)-System rinse for use with the ACL
AcuStar instrument.

911 IMP/IVD/2020/000321 Instrumentation HemosIL AcuStar von Willebrand Factor Ristocetin CDSCO Class C
Laboratory India Pvt Cofactor Activity(HemosIL)-The HemosIL AcuStar
Ltd von Willebrand Factor Ristocetin Cofactor Activity
(HemosIL AcuStar VWF:RCo) assay is a fully
automated chemiluminescent immunoassay for the
quantitative determination of von Willebrand Factor
Ristocetin Cofactor activity in human citrated
plasma on the ACL AcuStar™. The HemosIL
AcuStar VWF:RCo assay is indicated for use on
patients who, based on their clinical signs, are
suspected of having von Willebrand
Disease.,HemosIL AcuStar Anti-Cardiolipin
IgG(HemosIL)-Fully automated chemiluminescent
immunoassay for the semi- quantitative
measurement of anti-cardiolipin (aCL) IgG
antibodies in human citrated plasma and serum on
the ACL Acustar, as an aid in the diagnosis of
thrombotic disorders related to primary and
secondary Antiphospholipid Syndrome (APS)
when used in conjunction with other laboratory and
clinical findings.,HemosIL AcuStar Anti-Cardiolipin
IgM(HemosIL)-Fully automated chemiluminescent
immunoassay for the semi-quantitative
measurement of anticardiolipin (aCL) IgM
antibodies in human citrated plasma and serum on
the ACL AcuStar, as an aid in the diagnosis of
thrombotic disorders related to primary and
secondary Antiphospholipid Syndrome (APS)
when used in conjunction with other laboratory and
clinical findings.,HemosIL AcuStar Anti-(beta)2
Glycoprotein I IgG(HemosIL)-Fully automated
chemiluminescent immunoassay for the semi-
quantitative measurement of anti-ß2 Glycoprotein-I
(anti-ß2GPI) IgG antibodies in human citrated
plasma and serum on the ACL AcuStar, as an aid
in the diagnosis of thrombotic disorders related to

primary and secondary Antiphospholipid Syndrome
(APS) when used in conjunction with other
laboratory and clinical findings.,HemosIL Factor
XIII Antigen(HemosIL)-Automated latex enhanced
immunoassay for the quantitative determination of
Factor XIII Antigen (FXIII Ag) in human citrated
plasma on IL Coagulation Systems.,HemosIL
Acustar D-Dimer(HemosIL)-Fully automated
chemiluminescent immunoassay for the
quantitative determination of D-Dimer in human
citrated plasma on the ACL AcuStar as an aid in
the diagnosis of venous thromboembolism (VTE)
[deep vein thrombosis (DVT) and pulmonary
embolism (PE)].,HemosIL D-Dimer(HemosIL)-
Automated latex enhanced immunoassay for the
citrated plasma on IL Coagulation Systems for use
in conjunction with a clinical pretest probability
(PTP) assessment model to exclude venous
thromboembolism (VTE) in outpatients suspected
of deep venous thrombosis (DVT) and pulmonary
embolism (PE).,HemosIL
Homocysteine(HemosIL)-Automated latex
enhanced immunoassay for the quantitative
determination of total L-homocysteine in human
citrated plasma on IL Coagulation
Systems.,HemosIL Free Protein S(HemosIL)-
Automated latex ligand immunoassay for the
quantitative determination of free Protein S in
human citrated plasma on IL Coagulation
Systems.,HemosIL AcuStar HIT-IgG(PF4-H)
(HemosIL)-Fully automated chemiluminescent
immunoassay for the detection of IgG antibodies in
human citrated plasma and serum that react with
Platelet Factor 4 (PF4) when complexed to heparin
on the ACL AcuStar™. Heparin- associated

antibodies are commonly found in patients with
heparin induced thrombocytopenia or thrombosis
(HIT).,HemosIL D-Dimer HS(HemosIL)-HemosIL
D-Dimer HS is an automated latex enhanced
D-Dimer in humancitrated plasma on the ACL
TOP® Family and ACL TOP Family 50 Series for
use, in conjunction with a clinical pretest
probability (PTP) assessment model to exclude
venous thromboembolism (VTE) in outpatients
suspected of deep venousthrombosis (DVT) and
pulmonary embolism (PE).,HemosIL AcuStar Anti-
(beta)2 Glycoprotein I IgM(HemosIL)-Fully
automated chemiluminescent immunoassay for the
semi-quantitative measurement of Anti-ß2
Glycoprotein-I (Anti-ß2GPI) IgM antibodies in
human citrated plasma and serum on the ACL
AcuStar as an aid in the diagnosis of thrombotic
disorders related to primary and secondary
Antiphospholipid Syndrome (APS) when used in
conjunction with other laboratory and clinical
findings.,HemosIL von Willebrand Factor
Activity(HemosIL)-Automated latex enhanced
von Willebrand Factor Activity (VWF Activity) in
human citrated plasma on IL Coagulation
Systems.,HemosIL D-Dimer 500(HemosIL)-
Automated latex enhanced immunoassay for the
citrated plasma on IL Coagulation Systems for use
in conjunction with a clinical pretest probability
(PTP) assessment model to exclude venous
thromboembolism (VTE) in outpatients suspected
of deep venous thrombosis (DVT) and pulmonary
embolism (PE).,HemosIL AcuStar von Willebrand
Factor Antigen(HemosIL)-The HemosIL AcuStar

von Willebrand Factor Antigen (HemosIL AcuStar
VWF:Ag) assay is a fully automated
quantitative determination of von Willebrand Factor
antigen in human citrated plasma on the ACL
AcuStar™. The HemosIL AcuStar von Willebrand
Factor Antigen assay is indicated for use on
patients who, based on their clinical signs, are
suspected of having von Willebrand Disease.
912 IMP/IVD/2020/000322 KDH PNEUMOSLIDE IgM(PNEUMOSLIDE IgM CDSCO Class B

BIOMEDICALS PVT (Vircell))-Indirect immunofluorescent assay kit to
LTD test simulaneously IgM antibodies against the
main etiological agents of infectious disease of the
respairtory tract.
913 IMP/IVD/2020/000322 KDH COVID‐19 VIRCLIA IgM+IgA MONOTEST(Vircell)- CDSCO Class C

BIOMEDICALS PVT Indirect chemiluminescent immunoassay (CLIA) to
LTD test IgM+IgA antibodies against SARS‐CoV‐2 in
human serum/plasma.,SARS-COV-2 REALTIME
PCR KIT(Vircell)-Real Time RT-PCR kit to detect
nucleic acid from SARS-CoV-2 in human
respiratory samples. The test is a qualitative assay
to aid in the diagnosis of 2019 novel coronavirus
disease (COVID-19).,COVID‐19 VIRCLIA IgG
MONOTEST(Vircell)-Indirect chemiluminescent
immunoassay (CLIA) to test IgG antibodies against
SARS‐CoV‐2 in human serum/plasma.,COVID‐19
ELISA IgM+IgA(Vircell)-Indirect immunoenzyme
assay to test IgM+IgA antibodies against SARS‐
CoV‐2 in human serum/plasma,COVID‐19 ELISA
IgG(Vircell)-Indirect immunoenzyme assay to test
IgG antibodies against SARS‐CoV‐2 in human
serum/plasma

914 IMP/IVD/2020/000323 Trivitron Healthcare SARS-CoV-2 Antibody Test (Lateral Flow Method) CDSCO Class C
Pvt. Ltd. (NA)-Wondfo SARS-CoV-2 Antibody Test (Lateral
Flow Method) is an immunochromatographic
assay for rapid, qualitative detection of severe
acute respiratory syndrome coronavirus 2 (SARS-
CoV-2) IgG/IgM antibody in human whole blood,
serum or plasma sample. The test is to be used as
an aid in the diagnosis of coronavirus infection
disease (COVID-19), which is caused by SARS-
CoV-2.
915 IMP/IVD/2020/000324 True Healthcare :Humasis COVID-19 IgG/IgM Test(:Humasis CDSCO Class C
India Private COVID-19 IgG/IgM Test)-:Humasis COVID-19
Limited IgG/IgM test is one step in vitro diagnostic test
based on an immunochromatographic assay. It is
designed for qualitative detection of
Immunoglobulin G and Immunoglobulin M antibody
of Novel Coronavirus (COVID-19) in human blood.
916 IMP/IVD/2020/000329 Core Diagnostics SARS-CoV-2 Antibody Test(Lateral Flow Method)- CDSCO Class C
Pvt. Ltd. This product is an immunochromatographic assay
for rapid, qualitative detection of severe acute
respiratory syndrome coronavirus 2 (SARS-CoV-2)
IgG/IgM antibody in human whole blood, serum or
plasma sample. The test is to be used as an aid in
the diagnosis of coronavirus infection disease
(COVID-19), which is caused by SARS-CoV-2. The
test provides preliminary test results. Negative
results don’t preclude SARS-CoV-2 infection and
they cannot be used as the sole basis for
treatment or other management decision.

917 IMP/IVD/2020/000330 BIOHOUSE IgM-IgG Rapid Test(COVID-19)-BioMedomics CDSCO Class C

SOLUTIONS Rapid IgM-IgG Combined Antibody Test for
PRIVATE LIMITED COVID-19 is used to qualitatively detect IgG and
IgM antibodies of the novel coronavirus in human
serum, plasma or whole blood in vitro.
918 IMP/IVD/2020/000334 Roche Diagnostics cobas Lipid Panel(cobas Lipid Panel)-The cobas b CDSCO Class B
India Pvt. Ltd. 101 is an in vitro diagnostic test system designed
to quantitatively determine total cholesterol (TC),
high‑density lipoprotein cholesterol (HDL), and
triglycerides (TG) in human capillary and venous
whole blood or plasma by photometric
transmission measurement. A calculated value for
low‑density lipoprotein (LDL), non‑HDL and a
TC/HDL ratio is provided by the cobas b 101
system. The system is intended for professional
use in a clinical laboratory setting, or point of care
(PoC) locations.

919 IMP/IVD/2020/000334 Roche Diagnostics cobas HbA1c Test(cobas HbA1c Test)-The cobas b CDSCO Class C
India Pvt. Ltd. 101 is an in vitro diagnostic test system designed
to quantitatively determine the % hemoglobin A1c
(DCCT/NGSP) and mmol/mol hemoglobin A1c
(IFCC) in human capillary and venous whole blood
by photometric transmission measurement. An
estimated average glucose level (eAG) is
calculated by the cobas b 101 system. The system
is intended for professional use in a clinical
laboratory setting, or point of care (PoC) locations.
HbA1c determinations are useful for monitoring of
long‑term blood glucose control in individuals with
diabetes mellitus. Moreover, this test is to be used
as an aid in diagnosis of diabetes and identifying
patients who may be at risk for developing
diabetes.,cobas CRP Test(cobas CRP Test)-The
Roche cobas b 101 is an in vitro diagnostic test
system designed to quantitatively determine the
C‑reactive protein (CRP) in human capillary whole
blood and serum, EDTA K2/K3 and lithium heparin
anticoagulated whole blood and plasma by
photometric measurement. Measurement of CRP
is of use for the evaluation of inflammatory
disorders and associated diseases, infection and
tissue injury. The system is intended for use in
point‑of‑care (PoC) settings such as pharmacies,
physician offices, physician office laboratories,
clinics and hospitals, and clinical laboratory
settings.

920 IMP/IVD/2020/000337 Instrumentation HemosIL AcuStar ADAMTS13 Activity(HemosIL)- CDSCO Class C

Laboratory India Pvt The HemosIL AcuStar ADAMTS13 Activity is a
Ltd quantitative, fully automated, chemiluminescent
immunoassay (CIA) for the measurement of
ADAMTS13 Activity. The assay is for use in human
3.2% or 3.8% citrated plasma on the ACL AcuStar
® in a laboratory setting by healthcare
professionals. The assay results aid in the
diagnosis and monitoring of Thrombotic
Thrombocytopenic Purpura (TTP). The results
should be used in conjunction with other clinical
and laboratory findings. For use in adult
population. For prescription use only
921 IMP/IVD/2020/000338 Immunoshop India Immunofluorescence Analyzer (Lifotronic)-FA-160 CDSCO Class A

Pvt Ltd. Immunofluorescence Analyzer is an
immnofluorescence-based diagnostic system,
used for quantitative determination to the
concentration of various specific substance in
human body,Fully Automated ECL
Analyzer(Lifotronic)-eCL 8000 Fully Automated
ECL Analyzer is a small-sized fully automated
immunoassay analyzer for clinical use. This device
employs the tris (2,2’-bipyridine) ruthenium(II)-
based direct ECL method, and is used in
conjunction with matched test reagents.
,Hemoglobin Analyzer (HP LC) (Lifotronic)-HPLC is
a diagnosis device that is used for disease
screening. When diagnosing disease, clinicians
should take clinical examination results or other
test result into consideration

922 IMP/IVD/2020/000338 Immunoshop India Microalbumin (mAlb) Assay Kits(Lifotronic)-The CDSCO Class B
Pvt Ltd. mAlb Assay Kits is to be used with Lifotronic FA
series Lateral Flow Immunoassay Analyzer.
Applicable to quantitative measurement of the
content of mAlb in urine. ,Triiodothyronine（T3 )
Assay Kits(Lifotronic)-"Triiodothyronine （ T3 ）
Assay Kits is to be used with Lifotronic FA series
Lateral Flow Immunoassay Analyzer. Applicable to
quantitative measurement of the content of
T3.",Thyroid Stimulating Hormone (TSH）Assay
Kit(Lifotronic)-"Thyroid Stimulating Hormone
(TSH）Assay Kits is to be used with Lifotronic FA
content of TSH.. The results can be used in the
preliminary screening test of thyroid function."
,HbA1c Assay Kits(Lifotronic)-The HbA1c Assay
Kits is used with FA series Lateral Flow
Immunoassay Analyzer. Applicable to
quantitatively measurement of the content of
HbA1c in whole blood. ,HbA1c Reagent
Kits(HPLC)(Lifotronic)-Applicable to quantitative
examination the content of HbA1c in the whole
blood of human body with Lifotronic H series
hemoglobin analyzer. It adopts High Performance
Liquid Chromatography (HPLC) method to
measure the level of HbAlab, HbAlc and HbA0.
And the Analyzer calculates the rest items. ,β-
Human Chorionic Gonadotrophin (β-HCG) Assay
Kits(Lifotronic)-"The β -HCG Assay Kits is used
with FA series Lateral Flow Immunoassay
Analyzer. Applicable to quantitatively measurement
of the content of β-HCG in whole blood, serum,
plasma." ,Creatine Kinase MB (CK-MB) Assay Kits
(Lifotronic)-The CK-MB Assay Kits is used with FA

Applicable to quantitatively measurement of the
content of CK-MB in whole blood, serum,
plasma.,Myoglobin (Myo) Assay Kits (Lifotronic)-
The Mb Assay Kits is used with FA series Lateral
Flow Immunoassay Analyzer. Applicable to
quantitatively measurement of the content of Mb in
whole blood, serum, plasma.,Procalcitonin (PCT)
Assay Kits(Lifotronic)-The PCT Assay Kits is to be
used with FA series Lateral Flow Immunoassay
Analyzer. Applicable to quantitative measurement
of the content of PCT in whole blood, serum,
plasma. PCT is a peptideprecursorof the
hormonecalcitonin, the latter being involved
withcalciumhomeostasis. It is composed of 116
amino acidsand is produced by parafollicular
cells(C cells) of the thyroidand by the
neuroendocrine cellsof the lung and the
intestine,Thyroxine（T4）Assay Kits(Lifotronic)-
"Thyroxine （T4）Assay Kits is to be used with
Lifotronic FA series Lateral Flow Immunoassay
Analyzer. Applicable to quantitative measurement
of the content of Thyroxine." ,Thyroid Peroxidase
Antibody ( Electrochemiluminescence
Immunoassay)(Lifotronic)-"Immunoassay for in
vitro quantitative determination of antibody to
thyroid peroxidase in human serum and
plasma.",Myoglobin (Electrochemiluminescence
Immunoassay)(Lifotronic)-Immunoassay for in vitro
quantitative determination of Myoglobin in human
serum and plasma. The results can be used in
assisting diagnosis of myocardial
injury.,Lipoprotein-Associated Phospholipase A2
(Electrocheminluminescence Immunoassay)
(Lifotronic)-Immunoassay for in vitro quantitative
determination of Lp-PLA2 in human serum and
plasma.,Insulin (Electrochemiluminescence

Immunoassay)(Lifotronic)-Immunoassay for the in
vitro quantitative determination of Insulin in human
serum and plasma. Determination of Insulin is
used for evaluation of pancreatic islet function.,C-
peptide (Electrochemiluminescence
vitro quantitative determination of C-peptide in
human serum and plasma.",Testosterone
(Electrochemiluminescence Immunoassay)
determination of testosterone in human serum and
plasma. Clinically used for the auxiliary diagnosis
of diseases with abnormal level of testosterone,25-
OH Vitamin D Total (Electrochemiluminescence
quantitative determination of Total 25-hydroxy
Vitamin D in human serum and plasma. The
results can be used in assisting diagnosis of
Vitmain D sufficiency.,Thyroglobulin Antibody
(Lifotronic)-Immunoassay for the in vitro
quantitative determination of antibodies to
thyroglobulin in human serum and plasma.
Determination of anti-TG is used as an aid in the
detection of autoimmune thyroid diseases.,Ferritin
quantitative determination of ferritin in human
serum and plasma. It's mainly used for iron-
metabolism-related diseases, such as
hemochromatosis and iron-deficiency
anemia,Estradiol (Electrochemiluminescence
quantitative determination of 17β-estradiol (E2) in
human serum and plasma, which is clinically used
for auxiliary diagnosis of ovarian

diseases.,Interleukin-6 (Electrochemiluminescence
quantitative determination of Interleukin-6 (IL-6) in
human serum and plasma. This assay can be
used to aid in the management of critically ill
patients as an early indicator for acute
inflammation.,Folate (Electrochemiluminescence
vitro quantitative determination of folate in human
serum.,Follicle-stimulating Hormone
determination of follicle-stimulating hormone (FSH)
in human serum and plasma. The results mainly
used to evaluate pituitary endocrine
function.,Luteinizing Hormone
determination of luteinizing hormone(LH) in human
serum and plasma. The results mainly used to
evaluate pituitary endocrine function.,Parathyroid
Hormone (Electrochemiluminescence
immunoassay)(Lifotronic)-It's used for quantitative
determination of parathyroid hormone in human
serum or plasma in vitro.,Total Triiodothyronine Kit
（Electrochemiluminescence immunoassay）
(Lifotronic)-"Immunoassay for the in vitro
quantitative determination of Total triiodothyronine
in human serum and plasma.",Free Thyroxine Kit
quantitative determination of free thyroxine in
human serum and plasma.,Total Thyroxine Kit
quantitative determination of total thyroxine in

human serum and plasma,Free Triiodothyronine
Kit（Electrochemiluminescence immunoassay）
(Lifotronic)-"Immunoassay for the in vitro
quantitative determination of free triiodothyronine
in human serum and plasma.",Thyroid Stimulating
Hormone (Electrochemiluminescence
quantitative determination of thyrotropin in human
serum and plasma.,Human Chorionic
Gonadotropin (Electrochemiluminescence
quantitative determination of human chorionic
gonadotropin in human serum and
plasma.,Progesterone (Electrochemiluminescence
vitro quantitative determination of progesterone in
human serum and plasma.The results can be used
in the auxiliary diagnosis for premonitory
abortion.,Prolactin (Electrochemiluminescence
vitro quantitative determination of prolactin (PRL)
in human serum and plasma. It is mainly used to
evaluate the endocrine function of pituitary in
clinic, and can not be used for the auxiliary
diagnosis of hypophysoma.",Creatine Kinase MB
determination of creatine kinase MB in human
serum and plasma.,"N-terminal pro B-type
Natriuretic Peptide(Electrochemiluminescence
Immunoassay)"(Lifotronic)-Immunoassay for the in
vitro quantitative determination of N-terminal pro
B-type natriuretic peptide in human plasma.,Anti-
Mullerian Hormone (eCLIA)(Lifotronic)-
Immunoassay for in vitro quantitative
determination of Anti-Mullerian Hormone（AMH）

in human serum and plasma.,HbA1c Reagent Kit
(HPLC)(Lifotronic)-Applicable to quantitative
examination the content of HbA1c in the whole
blood of human body with Lifotronic H series
hemoglobin analyzer.,HbAlc Control
Material(Lifotronic)-HbAlc Control Material is
intended for the system quality control for accuracy
and repeatability.,HbAlc Calibrator(Lifotronic)-
НЬAlc Calibrator is intended for the percent
determination of HbAlc in human blood using High
Performance Liquid Chromatography
(HPLC).,Vitamin B12 (eCLIA)(Lifotronic)-
Immunoassay for in vitro quantitative
determination of Vitamin B12 in human serum and
plasma.

923 IMP/IVD/2020/000338 Immunoshop India D-Dimer STAT (eCLIA)(Lifotronic)-Immunoassay CDSCO Class C

Pvt Ltd. for in vitro quantitative determination of D-Dimer in
human plasma, which is mainly used for the
elimination of venous thrombosis, the auxiliary
diagnosis of disseminated intravascular
coagulation and the monitoring of thrombolytic
therapy.,Hypersensitivity C-reactive Protein (hs-
CRP) Assay Kits(Lifotronic)-The hs-CRP Assay
Kits is used with Lifotronic FA series Lateral Flow
quantitatively measurement of the content of CRP
in whole blood, serum, plasma.,Cystatin C (Cys-C)
Assay Kits(Lifotronic)-The Cys-C Assay Kits is to
be used with Lifotronic FA series Lateral Flow
Immunoassay Analyzer. Applicable to quantitative
measurement of the content of Cys-C in whole
blood, serum, plasma.,C-reactive Protein (CRP)
Assay Kits(Lifotronic)-"The CRP Assay Kits is used
with FA series Lateral Flow Immunoassay
Analyzer. Applicable to quantitatively measurement
of the content of CRP in whole blood, serum,
plasma." ,N-terminal Pro-Brain Natriuretic Peptide
(NT-proBNP) Assay Kits(Lifotronic)-The NT-
proBNP Assay Kits is to be used with Lifotronic FA
content of NT-proBNP in whole blood, serum,
plasma. ,D-dimer Assay Kits(Lifotronic)-The D-
dimer Assay Kits is to be used with FA series
quantitative measurement of the content of D-
dimer in whole blood, serum, plasma.,SARS-CoV-
2 IgG Assay Kits(Lifotronic)-For auxiliary diagnosis
of coronavirus disease COVID-19. ,Cardiac
Troponin (cTnI) Assay Kits(Lifotronic)-cTnI Assay
Kits is to be used with FA series Lateral Flow

quantitatively measurement of the content of cTnI
in whole blood, serum, plasma. ,SARS-CoV-2 IgM
Assay Kits(Lifotronic)-For auxiliary diagnosis of
coronavirus disease COVID-19. ,Heart Fatty Acid-
binding Protein(H-FABP) Assay Kits(Lifotronic)-
The H-FABP Assay Kits is used with FA series
quantitatively measurement of the content of H-
FABP in whole blood, serum, plasma.,High-
Sensitivity C-reactive Protein (
Electrochemiluminescence Immunoassay)
determination of C-reactive protein in human
serum and plasma,Thyroglobulin
quantitative determination of thyroglobulin in
human serum and plasma. Determination of Tg is
used as an aid in monitoring after thyroid
ablation,Calcitonin (Electrochemiluminescence
Immunoassay)(Lifotronic)-It’s used for quantitative
determination of calcitonin in human serum or
plasma in vitro, which mainly assists in diagnosis
of parathyroid function,Procalcitonin
quantitative determination of PCT (procalcitonin) in
human serum and plasma.,Troponin I
determination of cardiac troponin I in human serum
and plasma. This assay is intended to auxiliary
diagnosis of myocardial infarction

924 IMP/IVD/2020/000339 CliniExperts Tell Me Fast Coronavirus (COVID-19) IgG/IgM CDSCO Class C
Services Pvt. Ltd Antibody Test Cassette/Strip Format(Biocan)-
Biocan Tell Me Fast Coronavirus (COVID-19)
IgG/IgM Antibody Rapid Test is a rapid, qualitative,
membrane-based immunochromatographic in vitro
assay intended for detection and differentiation of
novel coronavirus (COVID-19) IgG & IgM
antibodies with human serum, plasma or whole
blood samples (including finger prick). This test is
intended for laboratory in vitro diagnostic use and
is a preliminary screening test and final diagnosis
should be based after examination with other
qualified assays.
925 IMP/IVD/2020/000341 Inbios India Cellex qSARS-CoV-2 IgG/IgM Cassette Rapid CDSCO Class C
Test(Cellex)-The Cellex qSARS-CoV-2 IgG/IgM
Cassette Rapid Test is a lateral flow immunoassay
for qualitative detection of antibodies to 2019 novel
coronavirus (SARS-CoV-2) in serum、 plasma or
whole blood specimens.

926 IMP/IVD/2020/000342 Becton Dickinson BD MAX Cdiff(BD MAX Cdiff)-The BD MAX™ Cdiff CDSCO Class C
India Private assay performed on the BD MAX System is an
Limited automated in vitro diagnostic test for the direct,
qualitative detection of the Clostridioides difficile
toxin B gene (tcdB) in human liquid or soft stool
specimens from patients suspected of having
Clostridioides difficile infection (CDI). The test,
performed directly on the specimen, utilizes real-
time polymerase chain reaction (PCR) for the
amplification of Clostridioides difficile toxin B gene
DNA and fluorogenic target-specific hybridization
probes for the detection of the amplified DNA. The
BD MAX Cdiff assay is intended to aid in the
diagnosis of CDI.,BD MAX Enteric Parasite
Panel(BD MAX Enteric Parasite Panel)-The BD
MAX Enteric Parasite Panel performed on the BD
MAX System is an automated in vitro diagnostic
test for the direct qualitative detection of enteric
parasitic pathogens. The BD MAX Enteric Parasite
Panel detects nucleic acids from: • Giardia lamblia
• Cryptosporidium (C. hominis and C. parvum only)
• Entamoeba histolytica Testing is performed on
unpreserved or 10% formalin-fixed stool
specimens from symptomatic patients with
suspected gastroenteritis, enteritis or colitis. The
assay is intended to aid in the diagnosis of
gastrointestinal infection when used in conjunction
with clinical evaluation and other laboratory
findings. The test is performed directly on the
specimen, utilizing real-time polymerase chain
reaction (PCR) for the amplification of specific
targets. The test utilizes fluorogenic gene-specific
hybridization probes for detection of the amplified
DNA. This test is intended for use, in conjunction
with clinical presentation, laboratory findings, and
epidemiological information, as an aid in the

differential diagnosis of Giardia lamblia,
Cryptosporidium hominis and C. parvum, as well
as Entamoeba histolytica infections. Results of this
test should not be used as the sole basis for
diagnosis, treatment, or other patient management
decision. Positive results do not rule out co-
infection with other organisms that are not
detected by this test, and may not be the sole or
definitive cause of patient illness. Negative results
in the setting of clinical illness compatible with
gastroenteritis and/or colitis may be due to
infection by pathogens that are not detected by
this test or non-infectious causes such as
ulcerative colitis, irritable bowel syndrome, or
Crohn’s disease.,BD SARS-CoV-2 Reagents for
BD MAX System(BD SARS-CoV-2 Reagents for
BD MAX System)-The BD SARS-CoV-2 Reagents
for BD MAX™ System is a real-time RT-PCR test
intended for the qualitative detection of nucleic
acid from the SARS-CoV-2 in nasal,
nasopharyngeal and oropharyngeal swab samples
from individuals suspected of COVID-19 by their
healthcare provider. Results are for the
identification of SARS-CoV-2 RNA. The SARS-
CoV-2 RNA is generally detectable in upper
respiratory samples during the acute phase of
infection. Positive results are indicative of the
presence of SARS-CoV-2 RNA; clinical correlation
with patient history and other diagnostic
information is necessary to determine patient
infection status. Positive results do not rule out
bacterial infection or co-infection with other
viruses. The agent detected may not be the
definite cause of disease. Negative results do not
preclude SARS-CoV-2 infection and should not be
used as the sole basis for patient management

decisions. Negative results must be combined with
clinical observations, patient history, and
epidemiological information. The BD SARS-CoV-2
Reagents for BD MAX System is intended for use
by qualified and trained clinical laboratory
personnel. specifically instructed and trained in the
techniques of real-time PCR, in vitro diagnostic
procedures, and use of the BD MAX System.,BD
MAX™ MRSA XT(BD MAX™ MRSA XT)-The BD
MAX™ MRSA XT assay performed on the BD
MAX System is an automated qualitative in vitro
diagnostic test for the direct detection of
methicillin-resistant Staphylococcus aureus
(MRSA) DNA from nasal swabs in patients at risk
for nasal colonization. The test utilizes real-time
polymerase chain reaction (PCR) for the
amplification of MRSA DNA and fluorogenic target-
specific hybridization probes for the detection of
the amplified DNA. The BD MAX MRSA XT assay
is intended to aid in the prevention and control of
MRSA infections in healthcare settings. It is not
intended to diagnose MRSA infections nor guide or
monitor treatment for MRSA infections. A negative
result does not preclude nasal colonization.
Concomitant cultures are necessary to recover
organisms for epidemiological typing or for further
susceptibility testing.,BD MAX Enteric Bacterial
Panel(BD MAX Enteric Bacterial Panel)-The BD
MAX™ Enteric Bacterial Panel performed on the
BD MAX System is an automated in vitro
diagnostic test for the direct qualitative detection
and differentiation of enteric bacterial pathogens.
The BD MAX Enteric Bacterial Panel detects
nucleic acids from: • Salmonella spp. •
Campylobacter spp. (jejuni and coli) • Shigella spp.
/ Enteroinvasive E. coli (EIEC) • Shiga toxin 1

(stx1) / Shiga toxin 2 (stx2) genes (found in Shiga
toxin-producing E. coli [STEC]) as well as Shigella
dysenteriae, which can possess a Shiga toxin
gene (stx) that is identical to the stx1 gene of
STEC. Testing is performed on unpreserved soft to
diarrheal stool specimens or Cary-Blair preserved
stool specimens from symptomatic patients with
suspected acute gastroenteritis, enteritis or colitis.
The test is performed directly on the specimen,
utilizing real-time polymerase chain reaction (PCR)
for the amplification of SpaO, a Campylobacter
specific tuf gene sequence, ipaH and stx1/stx2.
The test utilizes fluorogenic sequence-specific
hybridization probes for detection of the amplified
DNA. This test is intended for use, in conjunction
with clinical presentation, laboratory findings, and
epidemiological information, as an aid in the
differential diagnosis of Salmonella, Shigella/EIEC,
Campylobacter and Shiga toxin-producing E. coli
(STEC) infections. Results of this test should not
be used as the sole basis for diagnosis, treatment,
or other patient management decisions. Positive
results do not rule out co-infection with other
organisms that are not detected by this test, and
may not be the sole or definitive cause of patient
illness. Negative results in the setting of clinical
illness compatible with gastroenteritis may be due
to infection by pathogens that are not detected by
this test or non-infectious causes such as
ulcerative colitis, irritable bowel syndrome, or
Crohn’s disease,BD MAX StaphSR(BD MAX
StaphSR)-The BD MAX™ StaphSR assay
performed on the BD MAX System is an
automated qualitative in vitro diagnostic test for the
direct detection and differentiation of
Staphylococcus aureus (SA) DNA and methicillin-

resistant Staphylococcus aureus (MRSA) DNA
from nasal swabs in patients at risk for nasal
colonization. The test utilizes real-time polymerase
chain reaction (PCR) for the amplification of
MRSA/SA DNA and fluorogenic target-specific
hybridization probes for the detection of the
amplified DNA. The BD MAX StaphSR assay is
intended to aid in the prevention and control of
MRSA and SA infections in healthcare settings. It
is not intended to diagnose MRSA or SA infections
nor guide or monitor treatment for MRSA/SA
infections. A negative result does not preclude
nasal colonization. Concomitant cultures are
necessary to recover organisms for
epidemiological typing or for further susceptibility
testing.,BD MAX Extended Enteric Bacterial
Panel(BD MAX Extended Enteric Bacterial Panel)-
The BD MAX™ Extended Enteric Bacterial Panel
performed on the BD MAX System, is an
automated in vitro diagnostic test for the direct
qualitative detection and differentiation of enteric
bacterial pathogens. It is used in conjunction with
the BD MAX Enteric Bacterial Panel as an optional
Master Mix. The BD MAX Extended Enteric
Bacterial Panel detects nucleic acids from •
Plesiomonas shigelloides • Vibrio (V. vulnificus, V.
parahaemolyticus, and V. cholerae) •
Enterotoxigenic Escherichia coli (ETEC) heat-
labile enterotoxin (LT)/ heat-stable enterotoxin (ST)
genes • Yersina enterocolitica Testing is performed
on unpreserved soft to diarrheal or Cary-Blair
preserved stool specimens from symptomatic
patients with suspected acute gastroenteritis,
enteritis or colitis. The test is performed directly on
the specimen, utilizing real-time polymerase chain
reaction (PCR) for the amplification of relevant

gene target DNA. The test utilizes fluorogenic
gene-specific hybridization probes for the detection
of the amplified DNA. This test is intended for use,
in conjunction with clinical presentation, laboratory
findings, and epidemiological information, as an
aid in the differential diagnosis of Plesiomonas
shigelloides, Vibrio (V. vulnificus, V.
parahaemolyticus, and V. cholerae)
Enterotoxigenic Escherichia coli (ETEC) LT/ST and
Yersinia enterocolitica infections. Results of this
test should not be used as the sole basis for
diagnosis, treatment, or other patient management
decisions. Positive results do not rule out co-
infection with other organisms that are not
gastroenteritis may be due to infection by
pathogens that are not detected by this test or
non-infectious causes such as ulcerative colitis,
irritable bowel syndrome, or Crohn’s disease.,BD
MAX MDR-TB(BD MAX MDR-TB)-The BD MAX™
Multi Drug Resistant Tuberculosis (MDR-TB)
assay, performed on the BD MAX System, is an
automated qualitative in vitro diagnostic test for the
direct detection of Mycobacterium tuberculosis
complex (MTBC) DNA in raw sputum or
concentrated sputum sediments prepared from
induced or expectorated sputa In specimens
where MTBC DNA is detected, BD MAX MDR-TB
also detects mutations in the rpoB gene
associated with rifampin resistance as well as
mutations in the katG gene and inhA promoter
region both of which are associated with isoniazid
resistance.The test utilizes real-time polymerase
chain reaction (PCR) for the amplification of

specific DNA targets and fluorogenic, target-
specific hybridization probes to detect MTBC DNA
as well as the DNA associated with mutations in
the rpoB and katG genes and the inhA promoter
region associated with multidrug resistant TB. The
BD MAX MDR-TB assay is intended for use with
specimens frompatients for whomthere is clinical
suspicion of tuberculosis (TB) and who have not
received anti-tuberculosis therapy, or less than
three days of therapy in the past six months. This
test is intended as an aid in the diagnosis of
pulmonary tuberculosis when used in conjunction
with clinical and other laboratory findings.,BD MAX
Enteric Viral Panel (BD MAX Enteric Viral Panel)-
The BD MAX™ Enteric Viral Panel performed on
the BD MAX System, is an automated in vitro
diagnostic test for the direct qualitative detection
and differentiation of enteric viral pathogens. The
BD MAX Enteric Viral Panel detects nucleic acids
from • Norovirus GI & GII • Rotavirus A •
Adenovirus F40/41 • Sapovirus (genogroups I, II,
IV, V) • Human Astrovirus (hAstro) Testing is
performed on unpreserved soft to diarrheal or
Cary-Blair preserved stool specimens from
symptomatic patients with suspected acute
gastroenteritis, enteritis or colitis. The test is
performed directly on the specimen, utilizing real-
time polymerase chain reaction (PCR) for the
amplification of relevant gene target DNA/RNA.
The test utilizes fluorogenic gene-specific
hybridization probes for the detection of the
amplified DNA. This test is intended for use, in
conjunction with clinical presentation, laboratory
findings, and epidemiological information, as an
aid in the differential diagnosis of Norovirus GI &
GII, Rotavirus A, Adenovirus F40/41, Sapovirus

(genogroups I, II, IV, V), and hAstro infections.
Results of this test should not be used as the sole
basis for diagnosis, treatment, or other patient
management decisions. Positive results do not rule
out co-infection with other organisms that are not
gastroenteritis may be due to infection by
pathogens that are not detected by this test or
non-infectious causes such as ulcerative colitis,
irritable bowel syndrome, or Crohn’s disease.,BD
SARS-CoV-2 Reagents for BD MAX System(BD
SARS-CoV-2 Reagents for BD MAX System)-The
BD SARS-CoV-2 Reagents for BD MAX™ System
is a real-time RT-PCR test intended for the
qualitative detection of nucleic acid from the
SARS-CoV-2 in nasal, nasopharyngeal, and
oropharyngeal swab samples from individuals
suspected of COVID-19 by their healthcare
provider. Results are for the identification of SARS-
CoV-2 RNA. The SARS-CoV-2 RNA is generally
detectable in upper respiratory samples during the
acute phase of infection. Positive results are
indicative of the presence of SARS-CoV-2 RNA;
clinical correlation with patient history and other
diagnostic information is necessary to determine
patient infection status. Positive results do not rule
out bacterial infection or co-infection with other
viruses. The agent detected may not be the
definite cause of disease. Negative results do not
preclude SARS-CoV-2 infection and should not be
used as the sole basis for patient management
decisions. Negative results must be combined with
clinical observations, patient history, and
epidemiological information. The BD SARS-CoV-2

Reagents for BD MAX System is intended for use
by qualified and trained clinical laboratory
personnel specifically instructed and trained in the
techniques of real-time PCR, in vitro diagnostic
procedures, and use of the BD MAX System.,BD
MAX™ PCR Cartridges(BD MAX™ PCR
Cartridges)-The BD MAX, PCR Cartridges is an
IVD accessory that is used in conjunction with the
BD MAX instrument and used with all the BD MAX
assays. It is a plastic microfluidic cartridge into
which the sample is loaded, and the PCR reaction
takes place.,BDMAX ExK TNA-3(BDMAX ExK
TNA-3)-The BD MAX EXK TNA-3 is intended to
extract total nucleic acid (TNA) from swab
specimens in Universal Transport Medium (UTM).
The TNA Extraction Tube contains a Specimen
Processing Control sequence from a proprietary
Armored RNA Quant® (Asuragen, Inc). * The BD
MAX ExK TNA-3 has not been validated for use
with any specific test method.
927 IMP/IVD/2020/000343 Advy Chemical High-risk Human Papillomavirus (HPV) and CDSCO Class C
Private Limited genotyping 16&18 Real time PCR kit(Liferiver )-
High-Risk Human Papillomavirus (HPV) and
Genotyping16 & 18 Real-Time PCR Kit is used for
the detection of 14 HPV viruses to support the
diagnosis of HPV-caused cervix cancer.,High-risk
Human Papillomavirus (HPV) Genotyping Real
time PCR kit(Liferiver )-High-Risk Human
Papillomavirus（HPV）Genotyping Real Time
PCR Kit is used for the detection of 15 high-risk
HPV viruses in genital swab, cervical cell and
paraffin section samples with real time PCR
system.

928 IMP/IVD/2020/000343 ADVY CHEMICAL Novel Coronavirus (2019-nCoV) Real Time CDSCO Class C
PVT. LTD. Multiplex RT-PCR Kit(Novel Coronavirus (2019-
nCoV) Real Time Multiplex RT-PCR Kit)-Novel
Coronavirus(2019-nCoV)Real Time Multiplex RT-
PCR Kit (Detection for 3 Genes) is used for the in
vitro qualitative detection of 2019 novel
coronavirus (2019-nCoV) RNA in upper respiratory
tract specimens (nasopharyngeal and
oropharyngeal extracts) and lower respiratory tract
specimens (bronchoalveolar lavage fluid
(BALF)and deep cough sputum) by real time PCR
systems. It is considered as an aid in the diagnosis
of the 2019-nCoV infection.
929 IMP/IVD/2020/000344 Tata International SARS-CoV-2 Antibody Test (Lateral Flow Method) CDSCO Class C
Limited (SARS-CoV-2 Antibody Test (Lateral Flow
Method))-This product is an
immunochromatographic assay for rapid
qualitative detection of severe acute respiratory
syndrome coronavirus 2 (SARS-CoV-2) IgG/IgM
antibody in human whole blood, serum or plasma
sample. The test is to be used as an aid in the
diagnosis of coronavirus infection disease
(COVID-19), which is caused by SARS-CoV-2. The
test provides preliminary test results. Negative
results don’t preclude SARS-CoV-2 infection and
they cannot be used as the sole basis for
treatment or other management decision.

930 IMP/IVD/2020/000346 SYNERGY COVID 19 IgM/IgG-When the human body comes CDSCO Class C
SCIENTIFIC into contact with external antigens, the antibody
SERVICES IgM is produced first, followed by a large amount
PRIVATE LIMITED of antibody IgG. This test is used for qualitative
detection of 2019-new coronavirus IgG / IgM in
human serum, plasma, and whole blood for the
auxiliary diagnosis of new coronavirus infection in
clinical.
931 IMP/IVD/2020/000348 M/s. Elder Projects Novel Coronavirus(2019-nCoV) Diagnostic CDSCO Class C
Limited kit(SANSURE)-Novel Coronavirus(2019-nCoV)
Nucleic Acid Diagnostic Kit (PCR-Fluorescence
Probing) is used for qualitative detection of the
ORF1ab and N genes of novel coronavirus (2019-
nCoV) in nasopharyngeal swab, oropharyngeal
swab, alveolar lavage fluid, sputum, serum, whole
blood and feces from suspected pneumonia cases
with novel coronavirus infection, patients with
suspected clusters of novel coronavirus infection,
and other patients requiring diagnosis or
differential diagnosis of novel coronavirus
infection.

932 IMP/IVD/2020/000349 Immunoshop India Wash Concentrate(MAGLUMI)-MAGLUMI Wash CDSCO Class A

Pvt Ltd. Concentrate is intended to be diluted for
preparation of System Liquid which is required for
washing the magnetic mircobeads of the
MAGLUMI Fully-auto chemiluminescence
immunoassay (CLIA) analyzer. ,ISE
Cleaner(Biossays)-ISE Cleaner is used to wash
the ISE of Automatic Biochemistry Analyzer. ,Light
Check(MAGLUMI)-Light Check reagent required to
check the validity of Starter 1+2 as well as the
functioning of the measuring and pipetting units. A
Light Check has to be carried out on the
MAGLUMI series Fully-auto chemiluminescence
immunoassay analyzer either once daily prior to
starting the first measurement or whenever a new
lot of starter reagents is used. This control
program checks the proper functioning of the
instrument and starter reagents to avoid data error
due to instrument defects or mislocated or expired
starter reagents. ,Acid Wash(Biossays)-Acid Wash
is used to clean cross contamination of Automatic
Biochemistry Analyzer. ,Cuvette(Biossays)-
"Cuvettes required for the implementation of the
assayson the Biossays 240 Automatic
Biochemistry Analyzer." ,Waste Bag(MAGLUMI)-
"The MAGLUMI Waste Bag is used for collecting
waste produced during the tests on MAGLUMI
Fully‐auto chemiluminescence immunoassay
analyzer. " ,Reaction Module(MAGLUMI)-Reaction
Modules required for the implementation of the
MAGLUMI assays on the MAGLUMI series Fully-
auto chemiluminescence immunoassay analyzer.
,System Tubing Cleaning Solution(MAGLUMI)-The
MAGLUMI System Tubing Cleaning Solution is
used to clean the pipettor and the washer needles.
It is useful to minimize reagent carryover by

reducing protein precipitation in the tubing, and
improve routine maintenance of the MAGLUMI
system. The kit can only be used with MAGLUMI
Fully-auto chemiluminescence immunoassay
(CLIA) analyzer, with tubing cleaning program.
,Alkaline Wash(Biossays)-Alkaline Wash is used to
wash the piping, reagent probe and assay cup of
Automatic Biochemistry Analyzer.
,Hitergent(Biossays)-Hitergent is used to wash the
pentrough, reagent probe, stirring arm and assay
cup of Automatic Biochemistry Analyzer. ,Starter
1+2(MAGLUMI)-Starter reagent kit required to
generate the chemiluminometric light signal
necessary for the implementation of MAGLUMI
assays on the MAGLUMI Fully-auto
chemiluminescence immunoassay (CLIA)
analyzer. ,Fully-auto Nucleic Acid Purification
System(Molecision)-Used for extraction and
purification of nucleic acid in clinical
samples.,Fully-auto chemiluminescence
immunoassay analyzer(Maglumi)-Used in
conjunction with adapter reagents for qualitative
and/or quantitative analysis of the analytes in the
human sample. About Operating Instruction Issued
Date:,Fully-auto chemiluminescence immunoassay
analyzer(Maglumi)-Used in conjunction with
adapter reagents for qualitative and/or quantitative
analysis of the analytes in the human
sample.,Fully‐auto chemiluminescence
immunoassay analyzer(Maglumi)-Used in
conjunction with adapter reagents for qualitative
and/or quantitative analysis of the analytes in the
human sample.

933 IMP/IVD/2020/000349 Immunoshop India MAGLUMI - Anti-Sm IgG (CLIA)(MAGLUMI)-The CDSCO Class B
Pvt Ltd. kit is an in vitro chemiluminescence immunoassay
for the quantitative determination of IgG antibodies
to Sm (Anti-Sm IgG) in human serum and
plasma.,MAGLUMI - PAPP-A (CLIA)(MAGLUMI)-
The kit is an in vitro chemiluminescence
Pregnancy-associated plasma protein A (PAPPA)
in human serum.,MAGLUMI - free β-HCG (CLIA)
(MAGLUMI)-The kit is an in vitro
chemiluminescence immunoassay for the
quantitative determination of free β-chains of
human chorionic gonadotropin (free β-HCG) in
human serum.,Albumin Assay Kit (BCG)
(Biossays)-The Snibe BiossaysTM ALB reagent is
intended for the in vitro direct quantitative
determination of albumin in human serum. ,AⅠ
(CLIA)(MAGLUMI)-The kit is an in vitro
quantitative determination of Angiotensin Ⅰ(AⅠ) in
human plasma. ,EBV EA IgA (CLIA)(MAGLUMI)-
immunoassay for the qualitative determination of
EBV EA IgA in human serum. ,Osteocalcin (CLIA)
quantitative determination of Osteocalcin (BGP) in
human serum. ,EBV VCA IgM (CLIA)(MAGLUMI)-
EBV VCA IgM in human serum. ,Ferritin (CLIA)
quantitative determination of Ferritin in human
serum. ,C-Peptide (CLIA)(MAGLUMI)-The kit is an
in vitro chemiluminescence immunoassay for the

quantitative determination of C-Peptide in human
serum and plasma.,Insulin (CLIA)(MAGLUMI)-The
kit is an in vitro chemiluminescence immunoassay
for the quantitative determination of insulin in
human serum. ,T4 (CLIA)(MAGLUMI)-The kit is an
quantitative determination of Thyroxine (T4) in
human serum. ,T3 (CLIA)(MAGLUMI)-The kit is an
quantitative determination of Triiodothyronine (T3)
in human serum. ,Total bilirubin Assay Kit
(Vanadate)(Biossays)-The Snibe BiossaysTM TBIL
reagent is intended for quantitative determination
of total bilirubin in human serum. ,γ-Glutamyl
transferase Assay Kit (IFCC)(Biossays)-The Snibe
BiossaysTM GGT reagent is intended for
quantitative determination of γ-glutamyl
transferase in human serum. ,Alkaline
phosphatase Assay Kit (IFCC)(Biossays)-The
Snibe BiossaysTM ALP reagent is intended for
quantitative deter-mination of alkaline phosphatase
in human serum. ,Aspartate aminotransferase
Assay Kit (IFCC)(Biossays)-The Snibe
BiossaysTM AST reagent is intended for
quantitative de-termination of aspartate
aminotransferase in human serum. ,Alanine
aminotransferase Assay Kit (IFCC)(Biossays)-The
Snibe BiossaysTM ALT reagent is intended for
quantitative determi-nation of alanine
aminotransferase in human serum. ,Bile acid
Assay Kit (Enzyme Cycling)(Biossays)-The Snibe
BiossaysTM TBA reagent is intended for
quantitative determi-nation of total bile acids in
human serum. ,Homocysteine Assay Kit (Enzyme
Cycling)(Biossays)-The Snibe BiossaysTM Hcy

of homocysteine in human serum. ,Lipoprotein(a)
Assay Kit (Immunoturbidimetric)(Biossays)-The
Snibe BiossaysTM Lp(a) reagent is intended for
quantitative determination of lipoprotein(a) in
human serum. ,Apolipoprotein E Assay Kit
(Immunoturbidimetric)(Biossays)-The Snibe
BiossaysTM ApoE reagent is intended for
quantitative determination of apolipoprotein E in
human serum. ,Triglycerides Assay Kit (GPO-PAP)
(Biossays)-The Snibe BiossaysTM TG reagent is
intended for quantitative determination of
triglyceride in human serum. ,Total Cholesterol
Assay Kit (CHOD-PAP)(Biossays)-The Snibe
BiossaysTM TC reagent is intended for
quantitative determination of total cholesterol in
human serum. ,Low density lipoprotein cholesterol
Assay Kit (CAT)(Biossays)-The Snibe BiossaysTM
LDL-C reagent is intended for quantitative
determination of low density lipoprotein cholesterol
in human serum. ,High density lipoprotein
cholesterol Assay Kit (PPD)(Biossays)-The Snibe
BiossaysTM HDL-C reagent is intended for
quantitative determination of high density
lipoprotein cholesterol in human serum. ,25-OH
Vitamin D (CLIA) (MAGLUMI)-The kit is an in vitro
quantitative determination of 25-OH Vitamin D in
human serum. ,Anti-TPO (CLIA)(MAGLUMI)-The
for the quantitative determination of Anti-TPO in
human serum. ,EBV VCA IgA (CLIA)(MAGLUMI)-
EBV VCA IgA in human serum. ,EBV VCA IgG

qualitative determination of EBV VCA IgG in
human serum. ,Lactate dehydrogenase Assay Kit
(L→P)(Biossays)-The Snibe BiossaysTM LDH
of lactate dehydrogenase in human serum.
,Glucose Assay Kit (Hexokinase)(Biossays)-The
Snibe BiossaysTM GLU reagent is intended for
quantitative determination of glucose in human
serum. ,17 OH-Progesterone (CLIA)(MAGLUMI)-
17-OH PROGESTERONE in human serum. ,AMH
quantitative determination of Anti-Mullerian
Hormone (AMH) in human serum. ,Direct Renin
quantitative determination of Renin in human
EDTA-plasma specimens. ,Lp-PLA2 (CLIA)
(MAGLUMI)-The kit is an in vitro chemiluminescent
lipoprotein-associated phospholipase A2 (Lp-
PLA2) in human serum. ,Anti-IA2 (CLIA)
quantitative determination of tyrosine
phosphatase-like proteins antibody (Anti-IA2) in
human serum. ,ICA (CLIA)(MAGLUMI)-The kit is
an in vitro chemiluminescence immunoassay for
the quantitative determination of antibody to islet
cells of pancreas (ICA) in human serum. ,IGF-Ⅰ
quantitative determination of Insulin-like growth
factor-Ⅰ(IGF-Ⅰ) in human serum. ,Vitamin B12

quantitative determination of Vitamin B12 in
human serum. ,DHEA-S (CLIA)(MAGLUMI)-The kit
is an in vitro chemiluminescence immunoassay for
the quantitative determination of
dehydroepiandrosterone (DHEA-S) in human
serum. ,α-Amylase Assay Kit (EPS-G7)(Biossays)-
The Snibe BiossaysTM α-AMY reagent is intended
for quantitative determination of α-amylase in
human serum. ,AⅡ (CLIA)(MAGLUMI)-The kit is an
quantitative determination of Angiotensin Ⅱ (AⅡ) in
human plasma ,Inorganic Phosphorus (Molybdate)
(Biossays)-The Snibe BiossaysTM PHOS reagent
is intended for quantitative determination of
inorganic phosphorus (PHOS) in human serum.
,Calcium (OCPC)(Biossays)-The Snibe
BiossaysTM Ca reagent is used for quantitative
determination of Calcium in human serum. ,Iron
(Ferene)(Biossays)-The Snibe BiossaysTM Fe
reagent is used for quantitative determination of
Iron in human serum. ,ISE-REAGENT
PACK(Biossays)-ISE reagent is intended for
quantitative determination of K+, Na+, Cl- and
Ca2+ in human serum using the Automatic
Biochemistry analyzer BC1200 electrolyte module,
Electrolyte Analyzer (E1200) and Integrated
system (Biolumi 8000). ,FT3 (CLIA)(MAGLUMI)-
The kit is an in vitro chemiluminescent
Free Triiodothyronine (FT3) in human serum. ,FT4
quantitative determination of Free Thyroxine (FT4)
in human serum. ,TSH (CLIA)(MAGLUMI)-The kit

the quantitative determination of thyroid-
stimulating hormone (TSH) in human serum. ,Rev
T3 (CLIA)(MAGLUMI)-The kit is an in vitro
quantitative determination of Reverse
Triiodothyronine (RevT3) in human serum. ,TGA
quantitative determination of Thyroglobulin
autoantibody (TGA) in human serum. ,TMA (CLIA)
quantitative determination of Thyroid microsomal
autoantibody (TMA) in human serum. ,TRAb
quantitative determination of TSH receptor
antibodies (TRAb) in human serum. ,FSH (CLIA)
quantitative determination of FSH in human serum.
,LH (CLIA)(MAGLUMI)-The kit is an in vitro
quantitative determination of Luteinizing hormone
(LH) in human serum. ,PRL (CLIA) (MAGLUMI)-
PRL in human serum. ,PRG (CLIA)(MAGLUMI)-
progesterone (PRG) in human serum. ,Estradiol
(CLIA) (MAGLUMI)-The kit is an in vitro
quantitative determination of Estradiol in human
serum. ,Testosterone (CLIA)(MAGLUMI)-The kit is

the quantitative determination of Testosterone in
human serum. ,HCG/β-HCG (CLIA) (MAGLUMI)-
human chorionic gonadotropin (β-subunit) (HCG/β-
HCG) in human serum. ,free Estriol (CLIA)
quantitative determination of free Estriol in human
serum. ,free Testosterone (CLIA)(MAGLUMI)-The
for the quantitative determination of free
Testosterone in human serum. ,IgG (serum
analysis) (CLIA)(MAGLUMI)-The kit is an in vitro
quantitative determination of Immunoglobulin G
(IgG) in human serum. ,IgG (urine analysis) (CLIA)
quantitative determination of Immunoglobulin G
(IgG) in human urine. ,Albumin (CLIA)(MAGLUMI)-
Albumin in human urine. ,GH (CLIA)(MAGLUMI)-
Growth Hormone (GH). ,Cortisol (CLIA)
quantitative determination of cortisol in human
serum or urine ,Myoglobin (CLIA)(MAGLUMI)-The
for the quantitative determination of Myoglobin in
human serum. ,Proinsulin (CLIA)(MAGLUMI)-The

for the quantitative determination of proinsulin in
human serum. ,IgE (CLIA)(MAGLUMI)-The kit is
the quantitative determination of Immunoglobulin E
(IgE) in human serum. ,IgA (serum analysis)
quantitative determination of Immunoglobulin A
(IgA) in human serum.,IgA (urine analysis) (CLIA)
quantitative determination of Immunoglobulin A
(IgA) in human urine. ,IgM (CLIA)(MAGLUMI)-The
for the quantitative determination of
Immunoglobulin M (IgM) in human serum. ,IAA
quantitative determination of Insulin Autoantibodies
(IAA) in human serum. ,ACTH (CLIA)(MAGLUMI)-
Adrenocorticotropic Hormone (ACTH) in human
plasma. ,CK-MB (CLIA)(MAGLUMI)-The kit is an in
vitro chemiluminescence immunoassay for the
quantitative determination of MB isoenzyme of
creatine kinase (CK-MB) in human serum.
,Laminin (CLIA)(MAGLUMI)-The kit is an in vitro
quantitative determination of Laminin (LN) in
human serum. ,C Ⅳ (CLIA)(MAGLUMI)-The kit is
the quantitative determination of Type Ⅳ collagen
(CⅣ) in human serum. ,HA (CLIA)(MAGLUMI)-

Hyaluronic acid (HA) in human serum. ,PⅢP N-P
quantitative determination of Collagen Type Ⅲ N-
peptide (PⅢP N-P) in human serum. ,Aldosterone
quantitative determination of Aldosterone (ALD) in
human serum, plasma and treated urine. ,Intact
PTH (CLIA)(MAGLUMI)-The kit is an in vitro
quantitative determination of Intact Parathyroid
hormone (Intact PTH) in human serum. ,FA (CLIA)
quantitative determination of Folic Acid (FA) in
human serum.,PCT (CLIA)(MAGLUMI)-The kit is
the quantitative determination of PCT in human
serum, plasma and whole blood. ,GAD 65 (CLIA)
quantitative determination of glutamic acid
decarboxylase antibody (GAD65) in human serum.
,Cholylglycine (CLIA)(MAGLUMI)-The kit is an in
quantitative determination of Cholylglycine (CG) in
human serum. ,EBV EA IgG (CLIA)(MAGLUMI)-
EBV EA IgG in human serum. ,EBV NA IgG (CLIA)
qualitative determination of EBV NA IgG in human
serum. ,Direct bilirubin Assay Kit (Vanadate)
(Biossays)-The Snibe BiossaysTM DBIL reagent is

intended for quantitative determination of direct
bilirubin in human serum. ,Total protein Assay Kit
(Biuret)(Biossays)-The Snibe BiossaysTM TP
of total protein in human serum. ,Creatinine Assay
Kit (PAP)(Biossays)-The Snibe BiossaysTM Cr
of creatinine in human serum. ,Uric acid Assay Kit
(Uricase-PAP)(Biossays)-The Snibe BiossaysTM
UA reagent is intended for quantitative determina-
tion of uric acid in human serum. ,Urea Assay Kit
(Urease Kinetic)(Biossays)-The Snibe BiossaysTM
Urea reagent is intended for quantitative
determination of urea in human serum. ,Creatine
kinase (NAC activated) Assay Kit (IFCC)
(Biossays)-The Snibe BiossaysTM CK reagent is
intended for quantitative determination of creatine
kinase in human serum. ,Creatine kinase-MB
isozyme Assay Kit (Immunosuppression)
(Biossays)-The Snibe BiossaysTM CK-MB reagent
is intended for quantitative determination of
creatine kinase-MB in human serum. ,α-
hydroxybutyrate dehydrogenase Assay Kit (DGKC)
(Biossays)-The Snibe BiossaysTM α-HBDH
of alpha-hydroxybutyrate dehydrogenase in human
serum. ,IL-6 (CLIA)(MAGLUMI)-The kit is an in
quantitative determination of IL-6 in human serum
and plasma. ,ENA Screen (CLIA)(MAGLUMI)-The
for the quantitative determination of IgG class
antibodies to extractable nuclear antigens (ENA) in
human serum and plasma. ,Anti-SS-B IgG (CLIA)

quantitative determination of IgG antibodies to SS-
B (Anti-SS-B IgG) in human serum and plasma.
,Anti-nRNP/Sm IgG (CLIA)(MAGLUMI)-The kit is
the quantitative determination of IgG antibodies to
nRNP/Sm (Anti-nRNP/Sm IgG) in human serum
and plasma. ,Anti-M2-3E IgG (CLIA)(MAGLUMI)-
IgG antibodies to M2-3E (Anti-M2-3E IgG) in
human serum and plasma. ,Anti-Centromeres IgG
quantitative determination of IgG antibodies to
centromeres (Anti-Centromeres IgG) in human
serum and plasma. ,Anti-CCP (CLIA)(MAGLUMI)-
IgG autoantibodies to cyclic citrullinated peptides
(Anti-CCP) in human serum and plasma. ,Anti-Scl-
70 IgG (CLIA)(MAGLUMI)-The kit is an in vitro
quantitative determination of IgG antibodies to Scl-
70 (Anti-Scl-70 IgG) in human serum and plasma.
,Anti-Histones IgG (CLIA)(MAGLUMI)-The kit is an
quantitative determination of IgG antibodies to
histones (Anti-Histones IgG) in human serum and
plasma. ,Anti-dsDNA IgG (CLIA)(MAGLUMI)-The
for the quantitative determination of IgG
autoantibodies to double-stranded DNA (Anti-
dsDNA IgG) in human serum and plasma. ,Anti-
Rib-P IgG (CLIA)(MAGLUMI)-The kit is an in vitro
quantitative determination of IgG antibodies to Rib-

P (Anti-Rib-P IgG) in human serum and plasma.
,Anti-SS-A IgG (CLIA)(MAGLUMI)-The kit is an in
quantitative determination of IgG antibodies to SS-
A (Anti-SS-A IgG) in human serum and plasma.
,Anti-Jo-1 IgG (CLIA)(MAGLUMI)-The kit is an in
quantitative determination of IgG antibodies to Jo-
1 (Anti-Jo-1 IgG) in human serum and plasma.
,HER-2 (CLIA) (MAGLUMI)-The kit is an in vitro
quantitative determination of HER-2 in human
serum and plasma. ,ANA Screen (CLIA)
(MAGLUMI)-The kit is an in vitro chemiluminescent
IgG class antinuclear antibodies (ANA) in human
serum and plasma.

934 IMP/IVD/2020/000349 Immunoshop India MAGLUMI SARS-CoV-2 Neutralizing CDSCO Class C

Pvt Ltd. Antibody(MAGLUMI)-The kit is an in vitro
quantitative determination of neutralizing
antibodies to SARS-CoV-2 in human serum and
plasma using the MAGLUMI series Fully-auto
chemiluminescence immunoassay analyzer, and
the assay is used for an aid in identifying
individuals with an adaptive immune response to
SARS-CoV-2, indicating recent or prior infection.
The kit should not be used to diagnose acute
SARS-CoV-2 infection.,MAGLUMI - SARS-CoV-2
S-RBD IgG (CLIA)(MAGLUMI)-The kit is an In
Vitro chemiluminescence immunoassay for the
quantitative determination of S-RBD IgG
antibodies to SARS-CoV-2 in human serum and
plasma using the MAGLUMI series Fully-auto
chemiluminescence immunoassay analyzer.,Toxo
IgM (CLIA)(MAGLUMI)-The kit is an in vitro
qualitative determination of Toxo IgM in human
serum. ,HSV-1/2IgM (CLIA)(MAGLUMI)-The kit is
the qualitative determination of HSV-1/2 IgM in
human serum. ,CMV IgM(CLIA) (MAGLUMI)-The
for the qualitative determination of CMV IgM in
human serum. ,Rubella IgM (CLIA)(MAGLUMI)-
Rubella IgM in human serum. ,HSV-2 IgG (CLIA)
qualitative determination of HSV-2 IgG in human
serum. ,CMV IgG (CLIA)(MAGLUMI)-The kit is an

qualitative determination of CMV IgG in human
serum. ,Calcitonin (CLIA)(MAGLUMI)-The kit is an
quantitative determination of Calcitonin (CT) in
human serum. ,Troponin I (CLIA)(MAGLUMI)-The
for the quantitative determination of Troponin I in
human serum. ,CSA (CLIA)(MAGLUMI)-The kit is
the quantitative determination of Cyclosporine A
(CSA) in human whole blood.,CRP (CLIA)
quantitative determination of C-reactive protein
(CRP) in human serum. ,Digoxin(CLIA)
quantitative determination of digoxin in human
serum.,β2-MG (CLIA)(MAGLUMI)-The kit is an in
vitro chemiluminescent immunoassay for the
quantitative determination of β2-microglobulin (β2-
MG) in human serum or urine. ,TG (CLIA)
quantitative determination of Thyroglobulin (TG) in
human serum. ,FK506 (CLIA)(MAGLUMI)-The kit
the quantitative determination of FK 506 in human
whole blood.,hs-cTnI (CLIA)(MAGLUMI)-The kit is
the quantitative determination of cardiac Troponin I
(cTnI) in human serum and plasma. ,Toxo IgG
qualitative determination of Toxo IgG in human
serum. ,NT-proBNP (CLIA)(MAGLUMI)-The kit is

the quantitative determination of N-terminal
prohormone b-type natriuretic peptide (NT-
proBNP) in human serum. ,D-Dimer (CLIA)
plasma. ,HSV-1/2 IgG (CLIA)(MAGLUMI)-The kit is
the qualitative determination of HSV-1/2 IgG in
human serum. ,Rubella IgG (CLIA)(MAGLUMI)-
Rubella IgG in human serum. ,MAGLUMI - BNP
(CLIA)(MAGLUMI)-The BNP (CLIA) kit is an in
quantitative determination of BNP in human EDTA
plasma. Natriuretic peptides are a family of
structurally similar peptide hormones with the
function of natriuresis, promoting vasodilation and
inhibiting renin. BNP exists widely in brain, heart,
lung, digestive tract and so on. Among them, the
heart content is the highest, and the synthesis and
secretion of BNP in the heart is mainly in the
ventricle. BNP is a 32 amino acid peptide with a
central loop containing 17 amino-acids linked by a
disulfide bond between 2 cysteine residues.

935 IMP/IVD/2020/000350 SANYA SARS-CoV-2 Antibody Test (Lateral Flow Method) CDSCO Class C
HOSPITALITY PVT. (Wondfo)-WondfoSARS-CoV-2 Antibody Test
LTD. (Lateral Flow Method) is an Immune
chromatographic assay for rapid, qualitative
detection of severe acute respiratory syndrome
coronavirus 2 (SARS-CoV-2)IgG/IgM antibody in
human whole blood, serum or plasma sample. The
test is to be used as an aid in the diagnosis of
coronavirusinfection disease (COVID-19), which is
caused by SARS-CoV-2.
936 IMP/IVD/2020/000351 Renaissance Diagnostic Kit for IgM/IgG Antibody to Coronavirus CDSCO Class C
Pharmaceuticals (SARS-CoV-2) (Lateral Flow)(LIVZON)-This
product is used for in vitro qualitative detection of
Coronavirus (SARS-CoV-2) IgM/IgG antibody in
human serum, plasma and venous whole blood
samples.
937 IMP/IVD/2020/000354 GASTROLAB INDIA ScheBo SARS CoV2 Quick-The ScheBo® • CDSCO Class C
PVT. LTD. SARS-CoV-2 Quick™ is a visual
immunochromatographic rapid test for the
qualitative detection of SARS-CoV-2 IgM- and IgG-
antibodies from human serum, plasma and whole
blood samples.
938 IMP/IVD/2020/000356 Bio Science Sales SARS-CoV-2 IgG / IgM Ab Diagnostic Test Kit CDSCO Class C
Corporation (Coloidal Gold)(SARS-CoV-2 IgG / IgM Ab
Diagnostic Test Kit (Coloidal Gold))-For in vitro
qualitative determination of the content of SARS-
CoV-2 IgG/IgM antibody in human serum, plasma
and whole blood

939 IMP/IVD/2020/000358 DOCTOR'S Tell Me Fast Coronavirus (COVID-19) IgG/IgM CDSCO Class C
ANALYTICAL Antibody Rapid Test , Cassette/Strip
LABORATORIES format(Biocan)-Biocan Tell Me Fast Coronavirus
PVT LTD (COVID-19) IgG/IgM Antibody Rapid Test is a
rapid, qualitative, membrane-based
immunochromatographic in vitro assay intended
for detection and differentiation of novel
coronavirus (COVID-19) IgG & IgM antibodies with
human serum, plasma or whole blood samples
(including finger prick). This test is intended for
laboratory in vitro diagnostic use and is a
preliminary screening test and final diagnosis
should be based after examination with other
qualified assays.
940 IMP/IVD/2020/000359 VINCLAN Novel Coronavirus (2019-nCoV) RT-PCR CDSCO Class B

TECHNOLOGIES Detection Kit(Novel Coronavirus (2019-nCoV) RT-
PRIVATE LIMITED PCR Detection Kit)-This product is intended for the
rapid detection of 2019-nCOV in human throat
swab or sputum samples
941 IMP/IVD/2020/000360 Kin Diagnostics SGTi-flex COVID-19 IgM/IgG(SGTi-flex COVID-19 CDSCO Class C
IgM/IgG)-SGTi-flex COVID-19 IgM/IgG Test is an
immunoassay for qualitative detection of lgM or
IgG antibodies to COVID-19 in human whole
blood, serum or plasma. The test is useful as a
screening test for COVID-19

942 IMP/IVD/2020/000361 Biogeny Automated Hematology Analyzer(URIT)-The URIT- CDSCO Class A

Diagnostics Pvt. 3020 is appropriate to the qualitative and
Ltd. quantitative analysis of the visible components in
human beings blood.,Semi-Auto Chemistry
Analyzer(URIT)-It is intended for using to
quantitatively perform clinical biochemical items
analysis and immunology tests on a variety of
clinical samples, such as serum, urine,
cerebrospinal fluid and plasma, etc. by medical
and health institutions, medical scientific research
departments and so on.,Urine Analyzer(URIT)-This
instrument can be used in combination with urine
reagent strips for semi-quantitative or qualitative
detection of biochemical components in urine
samples, which can provide reference for clinical
examination and diagnosis. The items that can be
detected are Urobilinogen (URO), Bilirubin (BIL),
Ketone (KET), Blood (BLD), Protein (PRO), Nitrite
(NIT), Leukocyte (LEU), Glucose (GLU), Specific
Gravity (SG), pH, Microalbumin (MA), Creatinine
(CR), Vitamin C (VC) and Calcium (Ca), etc.,5-
part-Diff Auto Hematology Analyzer(URIT)-URIT-
5160 5-Part-Diff Auto Hematology Analyzer applies
to quantitative analysis of blood cells in clinical
examination.

943 IMP/IVD/2020/000361 Biogeny Urine Reagent Strips(URIT 14G)-URIT 14G urine CDSCO Class B
Diagnostics Pvt. reagent strips provide tests for the semi-
Ltd. quantitative measurement of leukocytes, ketone,
nitrite, urobilinogen, bilibrubin, glucose, protein,
specific gravity, pH, blood, ascorbic acid,
microalbumin, calcium and creatinine in
urine.,Urine Reagent Strips (URIT 10G)-URIT 10G
urine reagent strips provide tests for the semi-
quantitative measurement of leukocytes, ketone,
nitrite, urobilinogen, bilirubin, protein, glucose,
specific gravity, blood and pH in urine.

944 IMP/IVD/2020/000364 M/s.Roche Diabetes Quality Control Solution(ACCU-CHEK AVIVA CDSCO Class B
Care India Private CONTROL)-For performance checks on the Accu-
Limited Chek Aviva, Accu-Chek Aviva Nano, Accu-Chek
Aviva Connect, Accu-Chek Aviva Combo, Accu-
Chek Aviva Expert & Accu-Chek Aviva Insight
systems with the Accu-Chek Aviva test strips.
Testing control solutions with known glucose levels
establishes that the operator and the system are
performing acceptably. Control results must be
within the defined acceptable ranges before valid
patient testing is allowed. ,Quality Control
Solution(ACCU-CHEK PERFORMA CONTROL)-
For performance checks on the Accu-Chek
Performa system with the Accu-Chek Performa
test strips; and for performance checks on the
Accu-Chek Performa and the Accu-Chek Inform II
systems with the Accu-Chek Inform II test strips.
Testing control solutions with known glucose levels
establishes that the operator and the system are
performing acceptably. Control results must be
within the defined acceptable ranges before valid
patient testing is allowed.,Quality Control
Solution(ACCU-CHEK ACTIVE CONTROL)-The
control solution is intended for performing control
tests on Accu-Chek Active blood glucose meters
and Accu-Chek Active test strips.
945 IMP/IVD/2020/000366 MDAAC Coyote SARS-CoV-2 Direct Detect QPCR CDSCO Class C
International Private Assay(DirectDetectTM SARS-CoV-2 Detection
Limited Kit)-Detection of COVID-19
946 IMP/IVD/2020/000367 MDAAC COVID-19 IgM/IgG Antibody Rapid Test(Nova CDSCO Class C
International Private Test)-Detection of COVID-19
Limited

947 IMP/IVD/2020/000368 Abbott Diagnostics Panbio™ COVID-19 IgG/IgM RAPID TEST CDSCO Class C
Medical Private DEVICE(Panbio™ COVID-19 IgG/IgM RAPID
Limited TEST DEVICE)-"Panbio™ COVID-19 IgG/IgM
RAPID TEST DEVICE (Fingerstick Whole Blood/
Venous Whole Blood/Serum/Plasma) is for
professional use only and is intended to be used
as an aid in the diagnosis of SARS-CoV-2
infection. The Product may be used in any
laboratory and non-laboratory environment. The
test Provide preliminary test results. "
948 IMP/IVD/2020/000373 M/S Agappe SARS-CoV-2 Fluorescent PCR Kit-To identify and CDSCO Class C
Diagnostics Ltd specify the SARS-CoV-2 ,RNA Extraction Kit-For
extraction of RNA for COVID 19 testing . Used as
part of the PCR testing of COVID 19
949 IMP/IVD/2020/000375 Nucleus18 Turnkey Covid-19 Rapid Antiboby Test IVD Colloidal Gold CDSCO Class C
Projects Private Method(INNOVITA)-For testing of Corona Virus
Limited infection disease (Covid-19) which is caused by
SARS-CoV-2
950 IMP/IVD/2020/000376 Abbott Healthcare Total Bilirubin(Total Bilirubin)-The Total Bilirubin CDSCO Class B
Pvt. Ltd. assay is used for the quantitative analysis of total
bilirubin in human serum or plasma of adults and
neonates on the ARCHITECT c Systems.

951 IMP/IVD/2020/000377 M/s Parekh Lyra Direct SARS-CoV-2 Assay(Lyra Direct SARS- CDSCO Class C
Integrated Services CoV-2 Assay)-The Lyra Direct SARS-CoV-2 Assay
Pvt. Ltd. is a real-time RT-PCR assay intended for the
qualitative detection of nucleic acid from SARS-
CoV-2 in nasal (NS), nasopharyngeal (NP), or
oropharyngeal (OP) direct swab specimens from
patients suspected of COVID-19 by their
healthcare provider.,Lyra SARS-CoV-2 Assay(Lyra
SARS-CoV-2 Assay)-The Lyra SARS-CoV-2 Assay
is a real-time RT-PCR assay intended for the in
vitro qualitative detection of nucleic acid from
SARS CoV-2 in nasal, nasopharyngeal (NP) or
oropharyngeal (OP) swab specimens from patients
suspected of COVID-19 by their healthcare
provider. The Assay targets the non-structural
Polyprotein (pp1ab) of the SARS-CoV-2 virus. The
authorized testing consists of nucleic acid
extraction on the bioMerieux NucliSENS®
easyMAG® system or EMAG system, followed by
RT-PCR on the FDA-cleared real-time PCR
Instrument.

952 IMP/IVD/2020/000378 Becton Dickinson BD BBL Gram Stain Crystal Violet(BD BBL Gram CDSCO Class A
India Private Stain Crystal Violet)-Gram Stain Kits and
Limited Reagents are used to stain microorganisms from
cultures or specimens by the differential Gram
method.,BD BBL Gram Iodine (stabilized)(BD BBL
Gram Iodine (stabilized))-Gram Stain Kits and
Reagents are used to stain microorganisms from
cultures or specimens by the differential Gram
method.,BD BBL Gram Stain Kit(BD BBL Gram
Stain Kit)-Gram Stain Kits and Reagents are used
to stain microorganisms from cultures or
specimens by the differential Gram method.,BD
BBL Gram Decolorizer(BD BBL Gram Decolorizer)-
Gram Stain Kits and Reagents are used to stain
microorganisms from cultures or specimens by the
differential Gram method.,BD BBL Gram
Safranin(BD BBL Gram Safranin)-Gram Stain Kits
and Reagents are used to stain microorganisms
from cultures or specimens by the differential
Gram method.,BD Viper LT System PCR
Accessory Kit(BD Viper LT System PCR Accessory
Kit)-The PCR accessory kit is used in conjunction
with the Viper LT instrument and HPV Onclarity
assay and reagent. The provided plate seals are
used during the assay run set up and is placed on
the filled PCR plate by the instrument prior to
entering the reader,BD Viper LT PCR Tube/Tray
Kit(BD Viper LT PCR Tube/Tray Kit)-The BD Viper
LT PCR Tube/Tray Kit is used in conjunction with
the Viper LT instrument and HPV Onclarity assay
and reagents. Empty PCR tubes as provided in
this kit are used to completely fill the PCR plate if
less than a full plate of tubes is being run.

953 IMP/IVD/2020/000378 Becton Dickinson BD Onclarity HPV Assay LBC Diluent Tubes(BD CDSCO Class B
India Private Onclarity HPV Assay LBC Diluent Tubes)-The BD
Limited Onclarity Human Papillomavirus (HPV) Liquid-
Based Cytology (LBC) Diluent Tubes are designed
to allow for detection of Human Papillomavirus in
gynecological specimens that are collected in BD
SurePath™ Preservative Fluid or PreservCyt®
Solution and tested with the BD Onclarity HPV
Assay on the BD Viper™ LT System using an
aliquot that is removed prior to or after processing
for gynecological testing.,BD Onclarity HPV Self-
Collection Diluent Tube(BD Onclarity HPV Self-
Collection Diluent Tube)-BD Onclarity HPV Self-
Collection Diluent Tube is intended for the transfer
and resuspension of self collected vaginal
specimens in the laboratory for testing with the BD
Onclarity HPV Assay.
954 IMP/IVD/2020/000378 Becton Dickinson Control Set for the BD Onclarity HPV CDSCO Class C
India Private Assay(Control Set for the BD Onclarity HPV
Limited Assay)-The Control Set for the BD Onclarity HPV
Assay contains Positive and Negative Controls
that are intended for Quality Control use when
testing with the BD Onclarity HPV Assay on the BD
Viper LT instrument.
955 IMP/IVD/2020/000380 Almighty Techserv NUCLEIC ACID EXTRACTION KIT(KBM)-For CDSCO Class A
Nucleic acid extraction or purification kit.
Application in PCR, RT-PCR, Real Time qPCR and
Infectious disease research.

956 IMP/IVD/2020/000381 M/s. Elder Projects Novel Coronavirus (2019- nCoV) antibody test kit CDSCO Class C
Limited (colloidal gold method)(Novel Coronavirus (SARS-
CoV-2) Antibody (IgG/IgM) Test)-This kit is used for
the qualitative detection of Novel Coronavirus
(2019-nCoV) antibodies in Human Serum, Plasma
and Venous whole blood samples in vitro. It is only
used as a supplementary indicator for suspected
cases of novel coronavirus nucleic acid testing or
in conjunction with nucleic acid detection in the
diagnosis of suspected cases, and it cannot be
used as a basis for the diagnosis and conclusion
of Pneumonia caused by Novel Coronavirus, and
not suitable for general population screening. It is
only for Medical Institutions.

957 IMP/IVD/2020/000382 KDH Fungus 1-3 Beta- D Glucan Assay(Dynamiker CDSCO Class B
BIOMEDICALS PVT Fungus 1-3 Beta- D Glucan Assay)-(1 3) Beta D
LTD Glucan is the main cell wall component of most
fungi, such as Candida , Aspergillus and Fusarium
, etc. and does not exist in bacteria, virus or
human Fungus (1 3) Beta D Glucan Assay is
based on spectrophotometry for the quantitative
detection of (1 3) Beta D Glucan in human serum.
It offers a diagnostic reference for invasive fungal
diseases. The kit is intended for professional use
only.,Aspergillus Galactomannan
Assay(Dynamiker Aspergillus Galactomannan
Assay)-Dynamiker Aspergillus Galactomannan
Assay is based on sandwich Enzyme-linked
Immunosorbent Assay (ELISA). It is used for the
detection of Aspergillus galactomannan antigen in
human serum and bronchoalveolar lavage fluid
(BAL), offering a diagnostic reference for
Aspergillus infection. The kit is intended for
professional use only.,Candida Mannan
Assay(Dynamiker Candida Mannan Assay)-
Dynamiker Candida Mannan Assay is based on
competitive Enzyme-linked Immunosorbent Assay
(ELISA). It is used for quantitative detection of
Candida mannan antigen in human serum, offering
a diagnostic reference for Candida infection. The
kit is intended for professional use
only.,Cryptococcal Antigen Lateral Flow
Assay(Dynamiker Cryptococcal Antigen Lateral
Flow Assay)-Rapid immunochromatographic test
for the detection of capsular polysaccharide
antigens of Cryptococcus species complex
Cryptococcus neoformans and Cryptococcus gattii
in human serum and cerebral spinal fluid (CSF).

958 IMP/IVD/2020/000382 KDH 2019-nCOV IgG/IgM Rapid Test(Dynamiker)-The CDSCO Class C

BIOMEDICALS PVT 2019-nCOV IgG/IgM Rapid Test is based on rapid
LTD immunochromatographic test. It is used for the
detection of 2019 Novel Coronavirus (2019-Ncov)
IgG and IgM antibody in human whole
blood/serum/plasma, offering a diagnostic
reference for COVID-19,Novel Coronavirus (2019-
nCoV) RT-PCR Kit (Dynamiker)-Novel Coronavirus
(2019-nCoV) RT-PCR Kit is a polymerase chain
reaction IVD test to detect RNA of 2019-nCoV in
samples like upper respiratory tract samples
(throat swabs, nasal swabs, etc), lower respiratory
tract samples (respiratory tract extracts, bronchial
lavage fluid, alveolar lavage fluid, deep sputum,
etc), conjunctival swabs, stool specimens,
anticoagulant and serum

959 IMP/IVD/2020/000383 BIODX Serum Amyloid A Assay (Immunofluorescence) CDSCO Class B

HEALTHCARE (Serum Amyloid A Assay (Immunofluorescence))-
The kit is used for the quantitative in vitro detection
of Serum Amyloid A (SAA) in human serum,
plasma or whole blood samples.,T3 Assay
(Immunofluorescence)(T3 Assay
(Immunofluorescence))-The kit is used for the
quantitative in vitro detection of triiodothyronine in
human serum, plasma or whole blood samples.,T4
Assay (Immunofluorescence)(T4 Assay
quantitative in vitro detection of total thyroxine in
human serum, plasma or whole blood
samples.,TSH Assay (Immunofluorescence)(TSH
Assay (Immunofluorescence))-The kit is used for
the quantitative in vitro detection of thyroid
stimulating hormone (TSH) in human serum,
plasma or whole blood samples,Wash Buffer(Wash
Buffer)-It is used for cleansing the reaction system
during the testing process, so as to facilitate in
vitro testing of the tested substance. It does not
contain the wash buffer used separately for
instrument cleansing.,Glycosylated Hemoglobin
A1c Assay (Immunofluorescence)(Glycosylated
Hemoglobin A1c Assay (Immunofluorescence))-
of Glycosylated Hemoglobin A1c in human whole
blood samples.,25-hydroxyvitamin D
(Immunofluorescence)(25-hydroxyvitamin D
(Immunofluorescence))-It is used for
hydroxyvitamin D Assay (Immunofluorescence) is
used for the quantitative in vitro detection of 25
hydroxyvitamin D in human serum plasma and
whole blood.,Sample Treatment Matrix
Solution(Sample Treatment Matrix Solution)-This
kit is used to treat the microbe to be identified by

the mass spectrometry system.,Blood Culture
Positive Sample Pretreatment Kit(Blood Culture
Positive Sample Pretreatment Kit)-This kit is used
for cell crushing in positive blood culture medium,
separating and enriching of pathogenic bacteria.
Combined with the mass spectrometry system, the
pure culture of pathogenic microbe can be
obtained without subculture again, so as to detect
them quickly and accurately.,Microbe Sample
Pretreatment Kit(Microbe Sample Pretreatment
Kit)-This kit is used to pre-treat the microbe to be
identified by the mass spectrometry system. The
collected microbe protein spectrum is compared to
the database of mass spectra and the microbe is
identified based on the closest match.,Mold
Sample Pretreatment Kit(Mold Sample
Pretreatment Kit)-This kit is used for the pre-
treatment of freshly cultured mold on SDA plate.
The mold proteins can be obtained after treatment
by this kit. Combined with the mass spectrometry
system, it can identify common clinical
mold.,Substrate(Substrate)-It is used for in vitro
diagnostic testing based on the principle of
immunity with a variety of other reagents
(Chemiluminescence Immunoassay Kit supplied
by Zybio Inc.). It is only used for the specified
detection system.,Sample Diluent(Sample
Diluent)-It is used for dilution and liquefaction of
the test samples (serum, plasma), so as to
facilitate testing with in vitro diagnostic reagents or
instruments. It is not directly involved in the
detection. This sample dilution was used in
Automatic Chemiluminescence Immunoassay
Analyzer of Zybio Inc.

960 IMP/IVD/2020/000383 BIODX C-Reactive Protein Assay (Immunofluorescence) CDSCO Class C

HEALTHCARE (C-Reactive Protein Assay (Immunofluorescence))-
of C-Reactive Protein (CRP) in human serum,
plasma or whole blood samples.,cTnI Assay
(Immunofluorescence)(cTnI Assay
quantitative in vitro detection of cardiac troponin I
in human serum plasma and whole blood.,PCT
Assay (Immunofluorescence)(PCT Assay
quantitative in vitro detection of Procalcitonin
(PCT) in human serum, plasma or whole blood
samples.,D-Dimer Assay (Immunofluorescence)(D-
Dimer Assay (Immunofluorescence))-The kit is
used for the quantitative in vitro detection of D-
dimer in human whole blood or plasma
samples.,Interleukin-6 Assay
(Immunofluorescence)(Interleukin-6 Assay
(Immunofluorescence))-Interleukin-6 Assay
(Immunofluorescence) is used for the quantitative
in vitro detection of interleukin-6 (IL-6) in human
serum, plasma and whole blood.,NT-proBNP
Assay (Immunofluorescence)(NT-proBNP Assay
quantitative in vitro detection of NT-proBNP in
human serum, plasma or whole blood
samples.,Troponin T/CK-MB/Myoglobin Assay
(Immunofluorescence)(Troponin T/CK-
MB/Myoglobin Assay (Immunofluorescence))-
Troponin T/CK-MB/Myoglobin Assay
(Immunofluorescence) is used for the quantitative
in vitro detection of troponin T (cTnT), creatine
kinase isoenzyme (CK-MB) and myoglobin (Myo)
in human serum, plasma or whole blood
samples.,Troponin T Assay (Immunofluorescence)

(Troponin T Assay (Immunofluorescence))-The kit
is used for the quantitative in vitro detection of
Troponin T (cTnT) in human serum, plasma or
whole blood samples.,SARS-CoV-2 IgM IgG
Antibody Assay Kit (Colloidal Gold Method)(Zybio)-
qualitative detection of specific IgM antibodies and
IgG antibodies against novel coronavirus (SARS-
CoV-2) in human specimens (serum, plasma,
whole blood) ,SARS-CoV-2 Nucleic Acid Detection
Kit (PCR-Fluorescent Probe Method)(Zybio)-This
kit is used inqualitative detection in vitro of SARS-
CoV-2 RNA in sputum, throat swab, alveolar
lavage fluids specimens from suspected COVID-
19 cases, suspected clustered cases, other cases
requiring SARS-CoV-2 diagnosis or differential
diagnosis,Nucleic Acid Extraction Kit(Magnetic
Bead Method)(Zybio)-For the extraction,
enrichment and purification of nucleic acid
(DNA/RNA) in samples. Its processed products are
for clinical in vitro diagnostics ,SARS-CoV-2
Antigen Assay Kit (Colloidal Gold Method)(SARS-
CoV-2 Antigen Assay Kit (Colloidal Gold Method))-
This kit is used for the qualitative detection of
specific antigens to SARS-CoV-2 present in
human Oropharyngeal swab, nasopharynx
swab.,SARS-CoV-2 IgM/IgG Antibody Assay Kit
(Colloidal Gold Method)(SARS-CoV-2 IgM/IgG
Antibody Assay Kit (Colloidal Gold Method))-This
kit is used for the qualitative detection of specific
IgM antibodies and IgG antibodies against novel
coronavirus (SARS-CoV-2) in human specimens
(serum, plasma, whole blood).

961 IMP/IVD/2020/000384 NAMOHA BIO Covid-19 RT PCR kit(careGENE N-CoV RT-PCR CDSCO Class C
PRIVATE LIMITED kit, careGENE COVID-19 RT-PCR kit)-CareGENE
N-CoV RT-PCR kit & careGENE COVID-19 RT-
PCR kit are in vitro diagnostic medical device for
qualitative detection of coronavirus disease
(COVID-19) from RNA extracted from human
Nasopharyngeal swab, Oropharyngeal swab and
sputum using real-time RT-PCR (Reverse
transcription-Polymerase Chain Reaction).
962 IMP/IVD/2020/000385 BHARAT N - COV RT PCR kit(careGENE TM N-CoV RT – CDSCO Class C

PARENTERALS PCR Kit)-careGENE TM N-CoV RT – PCR Kit is in
LTD. an In vitro diagnostic for qualitative detection of
novel; coronavirus (COVID - 19) from RNA
extrcated from human Nasopharyngeal swab,
Orropharyngeal swab and sputum using real time
RT - PCR (Reverse transcription - polymerase
chain reaction).

963 IMP/IVD/2020/000386 A. Menarini India RADI PREP Swab and Stool DNA/RNA KIT(RADI CDSCO Class C
Private Limited PREP Swab and Stool DNA/RNA KIT)-The RADI
PREP Swab and Stool DNA / RNA KIT is a reagent
used to extract nucleic acids from bacteria and
viruses present in samples collected from human
feces, anus, vagina, or pharynx using cotton
swabs. The extracted nucleic acid can be used in
all experiments that require nucleic acids, such as
real-time PCR and NGS. The kit is for use by a
laboratory professional.,RADI COVID-19 Detection
Kit(RADI COVID-19 Detection Kit)-The RADI
COVID-19 Detection Kit is an in vitro diagnostic
medical device, based on real time RT-PCR
technology utilizing reverse-transcriptase (RT)
reaction to convert RNA into complementary DNA
(cDNA). It is intended for the presumptive
COVID-19 in upper and lower respiratory
specimens.
964 IMP/IVD/2020/000387 Siemens Healthcare Invisorb Spin Universal Kit(Invisorb Spin Universal CDSCO Class B
Private Limited Kit)-The Invisorb Spin Universal Kit is designed for
extraction and purification of DNA/RNA from 200
microliter sample material (for blood sample only
100 microliter) using the RTA spin Filter system
with capped spin columns
965 IMP/IVD/2020/000388 LAB X K-Assay factor-XIII Calibrator (KAI-206C)- CDSCO Class C

Calibration of Quantative determination of
Coagulation Factor-XIII in Plasma,K-Assay
Coagulation Control (K240C-10M)-Quality Control
for monitoring the performance of quantative
determination of coagulation Factor XIII.,K-Assay
factor-XIII (KAI-205)-Quantative determination of
Coagulation Factor-XIII in Plasma

966 IMP/IVD/2020/000389 Trivitron Healthcare SARS-CoV-2 IgG Assay Kits (Lateral Flow CDSCO Class C
Pvt. Ltd. Immunoassay)(NA)-Immunoassay for in vitro
qualitative determination of anti-SARS-CoV-2 IgG
antibodies in human blood sample.,SARS-CoV-2
IgM Assay Kits (Lateral Flow Immunoassay)(NA)-
Immunoassay for in vitro qualitative determination
of anti-SARS-CoV-2 IgM antibodies in human
blood sample.
967 IMP/IVD/2020/000390 Saffron Naturele Covid-19 IgG-IgM Rapid Test Cassette(NA)-The CDSCO Class C
Products Private COVID-19 IgG/IgM rapid test cassette is a lateral
Limited flow chromatography immunoassay for the
qualitative detection of anti-bodies (IgG and IgM)
to novel coronavirus in human whole
blood/serum/plasma. It provides an aid in the
diagnosis of infection with novel coronavirus.
968 IMP/IVD/2020/000391 Rihim Pharma abTES™COVID-19 qPCR I Kit(abTES™)-The CDSCO Class C

International LLP abTES™ COVID-19 qPCR I Kit is a qualitative
real-time polymerase chain reaction (qPCR) kit
which enables simultaneous detection of two
COVID-19- specific signature regions from its non-
structure polypeptide (orf1a) in a single reaction. It
also includes detection of human housekeeping
gene, GAPDH, as an Internal Control (IC) to
identify possible PCR inhibitions from sample
processing. The kit contains all the necessary PCR
reagents for rapid, sensitive and specific detection
using target-specific primers and double-labeled
hydrolysis probes. This kit has been validated on
samples extracted from sputum, nasopharyngeal
and throat swabs.

969 IMP/IVD/2020/000392 HORIBA INDIA Viral RNA Extraction Kit (NuActor)-NuActor Viral CDSCO Class C
Private Limited RNA Extraction Kit is a cartridge type extraction kit
intended for viral RNA purification from human
serum/plasma. For in vitro diagnostic use only.
,COVID-19 real-time PCR kit (L) (ExAmplar)-
ExAmplar COVID-19 real-time PCR kit (L) is a kit
for the in vitro qualitative detection of SARS-CoV-2
responsible for COVID-19 in respiratory
specimens. The primer and probe sets are
designed for the universal detection of
betacoronaviruses (E gene) and for specific
detection of COVID-19 (RdRp gene). For in vitro
diagnostic use only.
970 IMP/IVD/2020/000394 Genetix Biotech COVID 19 IgG/IgM Rapid Test Kit(SGTi-flex CDSCO Class C
Asia Pvt. Ltd. COVID-19 IgM/IgG kit)-SGTi-flex COVID-19
IgM/IgG Test is an immunoassay for qualitative
detection of lgM or IgG antibodies to COVID-19 in
human whole blood, serum or plasma. The test is
useful as a screening test for COVID-19.
971 IMP/IVD/2020/000395 PREMIER Novel Coronavirus (SARS-Cov-2) Antibody CDSCO Class C

NUTRACEUTICALS (IgG/IgM) Test-The Novel Coronavirus (SARS-
PRIVATE LIMITED CoV-2) Antibody (IgG/IgM) Test is a device that
utilizes immunochromatography for the qualitative
detection of Novel Coronavirus IgM/IgG antibody
in a serum, plasma or whole blood specimen. The
test is in a cassette format and intended for
professional use only. The device is for in vitro
diagnostic use.

972 IMP/IVD/2020/000396 M/s Vishat 1,25-Dihydroxy Vitamin D EIA-The IDS 1,25- CDSCO Class B
Diagnostic Pvt Ltd. Dihydroxy Vitamin D EIA kit is a complete assay
system intended for the purification of 1,25-
dihydroxyvitamin D (1,25D) in human serum or
plasma by immunoextraction followed by
quantitation by enzymeimmunoassay. Results are
to be used in conjunction with other clinical and
laboratory data to assist the clinician in the
assessment of 1,25D deficiency associated with
renal disease in adult populations.,Bone Tracp
(TRAcP 5b) Elisa-The BoneTRAP® assay is a
specific method to detect TRACP 5b activity
freshly libera- ted from osteoclasts. It is intended
for use as an indicator of bone resorption and can
be used as an aid in monitoring bone resorption
changes in post-menopausal women and
individuals diagnosed withosteoporosis undergoing
anti-resorptive therapies (HRT and
bisphosphonates) (4, 6-18). In vitro,TRACP 5b
activity reflects the number of osteoclasts (15,19),
and therefore the BoneTRAP® Assay can be
conveniently used to determine osteoclast number
in human osteoclast cultures ,Ostase® BAP EIA-
The Ostase® BAP EIA Immunoenzymetric Assay
is an in vitro device indicated for the quantitative
measurement of bone-specific alkaline
phosphatase (BAP), an indicator of osteoblastic
activity, in human serum. This device is intended to
be used as an aid in the management of
postmenopausal osteoporosis and Paget’s
disease.,N MID Osteocalcin® ELISA-The N-MID®
Osteocalcin ELISA is an enzyme immunological
test for the quantitative measurement of
osteocalcin, an indicator of osteoblastic activity in
human serum and plasma and is intended to be
used as an aid in the prevention of

osteoporosis,25-Hydroxy Vitamin DS EIA-The 25-
Hydroxy Vitamin DS EIA assay is intended for the
quantitative determination of 25-hydroxyvitamin D
[25(OH)D] and other hydroxylated metabolites in
human serum or plasma. Results are to be used in
conjunction with other clinical and laboratory data
to assist the clinician in the assessment of vitamin
D sufficiency.,AlphaCrossLaps® ELISA (CTX-I)-
The ALPHA CrossLaps® (CTX-I) EIA is an
enzyme-linked immunosorbent assay for the
quantification of non-isomerized fragments of C-
terminal telopeptides of Type-I collagen (α CTX-I)
in human urine. The ALPHA CrossLaps® (CTX-I)
EIA is intended for use as an indicator of
degradation of non-isomerized bone collagen and
may be used as an aid in the identification of
skeletal metastases in patients with breast and
prostate cancer ,Urine BETA CrossLaps (CTX-I)
ELISA-The Urine BETA CrossLaps® (CTX-I)ELISA
is an enzyme immunological test for the
quantification of degradation products of C-
terminal telopeptides of Type-I collagen in human
urine,Serum CrossLaps® ELISA (CTX-I)-The
Serum CrossLaps® (CTX-I) ELISA is an enzyme
immunological test for the quantification of
degradation products of C-terminal telopeptides of
Type I collagen in human serum and plasma. The
Serum CrossLaps® (CTX-I) ELISA assay is
intended for in vitro diagnostic use as an indication
of human bone resorption and may be used as an
aid in Monitoring bone resorption changes and
Predicting skeletal Response (Bone Mineral
Density) in postmenopausal women undergoing
anti resorptive therapies ,Urine CrossLaps® ELISA
(CTX-I)-The Urine CrossLaps® (CTX-I) EIA is an
enzyme immunosorbent assay for quantitative

determination of degradation products of C-
terminal telopeptides of Type-I collagen in human
urine. The Urine CrossLaps® (CTX-I)EIA assay is
intended for in vitro diagnostic use as an indication
of human bone resorption and may be used as an
aid in Monitoring bone resorption changes and
Predicting skeletal response (Bone Mineral
Density) in postmenopausal women undergoing
anti-resorptive therapies. ,25-Hydroxy Vitamin D
RIA(25-Hydroxy Vitamin D RIA)-The IDS 25-
Hydroxy Vitamin D RIA kit is a liquid phase
radioimmunoassay intended for the quantitative
determination of 25-hydroxyvitamin D (25-OH D)
and other hydroxylated metabolites in human
serum or plasma. Results are to be used in
conjunction with other clinical and laboratory data
to assist the clinician in the assessment of vitamin
D sufficiency.
973 IMP/IVD/2020/000397 RAPID Hematology Analyzer Diluent-To dilute blood for CDSCO Class B
DIAGNOSTIC PVT. further testing using Hematology Analyzer, such as
LTD. Complete Blood Count (CBC),Hematology
Analyzer Lyse-To lyse the cells for further testing
using Hematology Analyzer, such as Complete
Blood Count (CBC),Cleanser-For cleaning various
parts of Hematology Analyzer like probe, needles,
bath, tubing etc.,Hematology Control-Hematology
Control is used for the quality control of
Hematology Analyzer,Hematology Calibrator-
Hematology Calibrator is used in the calibration of
Hematology Analyzer

974 IMP/IVD/2020/000398 Asvin Diagnostics Triglycerides(Triglycerides)-Quantitative CDSCO Class B

Pvt. Ltd., determination of in Triglycerides serum only for in
vitro use in clinical chemistry ,LDLc-D(LDLc-D)-
Quantitative determination of Low Density Lipo
Proteins in serum only for in vitro use in clinical
chemistry ,Total Protein (Total Protein )-
Quantitative determination of Total Protein in
serum only for in vitro use in clinical chemistry
,Total Lipids(Total Lipids)-Quantitative
determination of Total Lipids in serum only for in
vitro use in clinical chemistry ,CK –MB LQ(CK –
MB LQ)-Quantitative determination of Creatinine
Kinease(MB) in serum only for in vitro use in
clinical chemistry ,GOT/AST LQ(GOT/AST LQ)-
Quantitative determination of GOT/AST in serum
only for in vitro use in clinical chemistry
,Cholesterol (Cholesterol )-Quantitative
determination of Cholesterol in serum only for in
vitro use in clinical chemistry ,Chloride (Chloride )-
Quantitative determination of Chloride in serum
only for in vitro use in clinical chemistry ,Ammonia
(NH3)(Ammonia (NH3))-Quantitative determination
of Ammonia in serum only for in vitro use in clinical
chemistry ,GPT/ALT (GPT/ALT )-Quantitative
determination of GPT/ALT in serum only for in vitro
use in clinical chemistry ,Phosphorus
UV(Phosphorus UV)-Quantitative determination of
Phosphorus in serum only for in vitro use in clinical
chemistry ,Protein U & CFS(Protein U & CFS)-
Quantitative determination of Protein U & CFS in
,Phospholipids(Phospholipids)-Quantitative
determination of Phospholipids in serum only for in
vitro use in clinical chemistry , GPT/ALT LQ(
GPT/ALT LQ)-Quantitative determination of
GPT/ALT LQ in serum only for in vitro use in

clinical chemistry ,Iron FZ(Iron FZ)-Quantitative
determination of Iron in serum only for in vitro use
in clinical chemistry ,LDH LQ(LDH LQ)-
Quantitative determination of Lactate
dehydrogenase in serum only for in vitro use in
clinical chemistry ,Lipase LQ(Lipase LQ)-
Quantitative determination of Lipase in serum only
for in vitro use in clinical chemistry ,Magnesium
(Magnesium )-Quantitative determination of
Magnesium in serum only for in vitro use in clinical
chemistry ,TIBC(TIBC)-Quantitative determination
of in serum only for in vitro use in clinical chemistry
,Bilirubin T-DMSO(Bilirubin T-DMSO)-Quantitative
determination of Bilirubin T- DMSO in serum only
for in vitro use in clinical chemistry ,Calcium A-
III(Calcium A-III)-Quantitative determination of
Calcium in serum only for in vitro use in clinical
chemistry ,Cholesterol LS(Cholesterol LS)-
Quantitative determination of Cholesterol in serum
only for in vitro use in clinical chemistry ,y- GT
LQ(y- GT LQ)-Quantitative determination of
Gamma Gultamyltrasnferase in serum only for in
vitro use in clinical chemistry,ACP(ACP)-
Quantitative determination of Acid Phosphates in
serum only for in vitro use in clinical chemistry ,CK
NAC-LQ(CK NAC-LQ)-Quantitative determination
of Creatinine Kinease (CK) in serum only for in
vitro use in clinical chemistry ,Amylase
LQ(Amylase LQ)-Quantitative determination of
Amylase in serum only for in vitro use in clinical
chemistry ,ALP LQ(ALP LQ)-Quantitative
determination of Alkaline Phosphates in serum
only for in vitro use in clinical chemistry ,Albumin
(Albumin )-Quantitative determination of Albumin in
serum only for in vitro use in clinical chemistry,CK
MB Control(CK MB Control)-Serum control for CK

MB clinical chemistry assays. ,Microalbumin Turbi
(Microalbumin Turbi )-Quantitative determination of
μ Microalbumin in serum only for in vitro use in
clinical chemistry ,IgE Turbi (IgE Turbi )-
Quantitative detection of Allergy Level in serum
only for in vitro use in clinical chemistry ,Ferritin
Turbi(Ferritin Turbi)-Quantitative determination of
Ferritin in serum only for in vitro use in clinical
chemistry ,Lp(A) TURBI(Lp(A) TURBI)-Quantitative
measurement of Lipo Protein A in serum only for in
vitro use in clinical chemistry ,CRP TURBI(CRP
TURBI)-Quantitative measurement of CRP in
serum only for in vitro use in clinical chemistry ,RF
TURBI(RF TURBI)-Quantitative measurement of
RF in serum only for in vitro use in clinical
chemistry ,Creatinine - J(Creatinine - J)-
Quantitative determination of Creatinine in serum
only for in vitro use in clinical chemistry ,ASO
TURBI (ASO TURBI )-Quantitative measurement
of ASLO in serum only for in vitro use in clinical
chemistry ,RF Latex(RF Latex)-Qualitative
measurement of RF (Rheumatoid factors) in serum
only for in vitro use in clinical chemistry ,CRP
Latex(CRP Latex)-Qualitative measurement of
CRP (C-Reactive Protein) in serum only for in vitro
use in clinical chemistry ,ASO Latex (ASO Latex )-
Qualitative measurement of ASO (Anti-Streptolysis
O) in serum only for in vitro use in clinical
chemistry ,Creatinine TR(Creatinine TR)-
Quantitative determination of Creatinine in serum
only for in vitro use in clinical chemistry ,Uric Acid
Ls(Uric Acid Ls)-Quantitative determination of in
Uric Acid serum only for in vitro use in clinical
chemistry ,Uric Acid(Uric Acid)-Quantitative
determination of in Uric Acid serum only for in vitro
use in clinical chemistry ,Urea UV LQ(Urea UV

LQ)-Quantitative determination of in Urea serum
only for in vitro use in clinical chemistry
,CHE/Colinesterase(CHE/Colinesterase)-
Quantitative determination of Cholinesterase/CHE
in serum only for in vitro use in clinical chemistry
,GOT/AST(GOT/AST)-Quantitative determination
of GOT/AST in serum only for in vitro use in clinical
chemistry ,HDLc-D(HDLc-D)-Quantitative
determination of High Density Lipo Proteins in
,Triglycerides Ls(Triglycerides Ls)-Quantitative
determination of in Triglycerides serum only for in
vitro use in clinical chemistry ,Bilirubin D-
DMSO(Bilirubin D-DMSO)-Quantitative
determination of Bilirubin D-DMSO in serum only
for in vitro use in clinical chemistry
975 IMP/IVD/2020/000402 N.W. OVERSEAS SARS-CoV-2 Antibody Test (colloidal gold CDSCO Class C
immunochromatography)(Lepu)-The product is
intended for the qualitative detection of antibody
content against SARS-CoV-2 in clinical samples
(serum/plasma/whole blood).
976 IMP/IVD/2020/000404 Bioplus Healthcare Cellex qSARS- CoV-2 IgG/IgM Cassette Rapid CDSCO Class C
Private Limited Test-The Cellex qSARS-CoV-2 IgG/IgM Cassette
Rapid Test is a lateral flow immunoassay for
qualitative detection of antibodies to 2019 novel
coronavirus (SARS-CoV-2) in serum,plasma or
whole blood specimens.
977 IMP/IVD/2020/000406 S A Diagnostics Novel Coronavirus (2019-nCoV) IgM/IgG Antibody CDSCO Class C
Private Limited Test Kit (Colloidal Gold)(Genrui)-For in vitro
qualitatively detecting novel coronavirus (2019-
nCoV) IgM and IgG antibodies in human serum,
plasma or whole blood.

978 IMP/IVD/2020/000407 CRONIES Dow QuickFinder ™ 2019-nCoV Real time PCR CDSCO Class C
PHARMA AND BIO- Kit(Dow QuickFinder ™ 2019-nCoV Real time
SCIENCES PVT. PCR Kit)-Dow QuickFinder™ 2019-nCoV Real
LTD. time PCR Kit is intended for the qualitative
determination of corona virus from phlegm,
oropharyngeal and nasopharyngeal swab using
real-time reverse-transcription PCR method. "Dow
QuickFinderTM 2019-nCoV Real-time PCR Kit is a
product that can detect three specific target
regions of N gene among specific target genes in
Corona 19 using real-time polymerase chain
reaction. The real-time polymerase chain reaction
method uses fluorescent materials to measure the
signals from each cycle of PCR in real time to
compensate for the shortcomings of the end-point
detection of existing PCR, and detects PCR
amplification products through fluorescence. cDNA
synthesis and target region detection can be
performed simultaneously with a single PCR using
a one-step method, thereby detecting corona 19 in
a shorter time compared to the time required for
the existing test. This product extracts RNA from
human samples (sputum, oropharyngeal and
nasopharyngeal smears, etc.) and then uses real-
time reverse-transcription PCR to detect 3 of the N
genes of Corona19 virus. It is a medical device for
in vitro diagnosis that helps to diagnose corona19
virus infection by detecting the target region."
979 IMP/IVD/2020/000411 ALLIANZ Viral RNA Extraction Kit(Ribospin™ vRD - CDSCO Class C
BIOINNOVATION GeneAll)-Extraction of Viral RNA from patient
sample

980 IMP/IVD/2020/000412 M/s Vishat Scrub typhus Rapid(ImmuneMed)-"ImmuneMed CDSCO Class B

Diagnostic Pvt Ltd. Scrub typhus Rapid" is an
ImmunoChromatographic Assay for qualitative
detection of IgM & IgG antibodies to Orientia
tsutsugamushi in the patient's serum, plasma or
whole blood.
981 IMP/IVD/2020/000413 Beckman Coulter QMS Tacrolimus Immunoassay (QMS Tacrolimus CDSCO Class B
India Private Immunoassay )-The QMS Tacrolimus
Limited Hisaria Immunoassay is intended for the quantitative
Warehouse Ground determination of tacrolimus in human whole blood
Floor on automated clinical chemistry analyzers. The
results obtained are used as an aid in the
management of kidney, liver, and heart transplant
patients receiving tacrolimus therapy. This in vitro
diagnostic device is intended for clinical laboratory
use only.,CEDIA Cyclosporin PLUS Assay (CEDIA
Cyclosporin PLUS Assay )-The CEDIA®
Cyclosporine PLUS assay is for the in vitro
quantitative determination of cyclosporine in
human whole blood using automated clinical
chemistry analyzers as an aid in the management
of cyclosporine therapy in kidney, liver, and heart
transplants

982 IMP/IVD/2020/000413 Beckman Coulter MAS Liquid Mycophenolic Acid Control Level CDSCO Class C
India Private 3(MAS Liquid Mycophenolic Acid Control Level 3)-
Limited Hisaria MAS Mycophenolic Acid (MPA) Controls are
Warehouse Ground intended for use as assayed quality control
Floor material for validation of MPA assays.,QMS
Everolimus Immunoassay Reagent(QMS
Everolimus Immunoassay Reagent)-The QMS
Everolimus assay is to be used for the quantitative
determination of everolimus in human whole blood
on automated clinical chemistry analyzers.,MAS
Liquid Mycophenolic Acid Control Level 2(MAS
Liquid Mycophenolic Acid Control Level 2)-MAS
Mycophenolic Acid (MPA) Controls are intended
for use as assayed quality control material for
validation of MPA assays,QMS Everolimus
Immunoassay Control(QMS Everolimus
Immunoassay Control Set)-The QMS Everolimus
Control set is intended for use in quality control of
the QMS Everolimus assay.,CEDIA Mycophenolic
Acid Assay(CEDIA Mycophenolic Acid Assay)-The
CEDIA® Mycophenolic Acid (MPA) Assay is an in
vitro diagnostic medical device intended for the
quantitative measurement of mycophenolic acid in
human plasma using automated clinical chemistry
analyzers as an aid in the management of
mycophenolic acid therapy in renal and cardiac
transplant patients.,QMS Tacrolimus Immunoassay
Calibrator(QMS Tacrolimus Immunoassay
Calibrator Set)-The QMS Tacrolimus Calibrator set
is intended for use in calibration of the QMS
Tacrolimus Immunoassay,MAS Liquid
Mycophenolic Acid Control Level 1(MAS Liquid
Mycophenolic Acid Control Level 1)-MAS
Mycophenolic Acid (MPA) Controls are intended
for use as assayed quality control material for
validation of MPA assays.,CEDIA Mycophenolic

Acid Calibrators(CEDIA Mycophenolic Acid
Calibrators)-The CEDIA Mycophenolic Acid (MPA)
Calibrators are intended for use in the calibration
of the CEDIA MPA Assay.,CEDIA Cyclosporine
PLUS High Range Calibrators(CEDIA
Cyclosporine PLUS High Range Calibrators)-The
CEDIA Cyclosporine PLUS High Range calibrators
are used to calibrate the CEDIA Cyclosporine
PLUS High Range Assay in human whole blood.
Each calibrator set is sold separately and may be
used with any reagent lot.,QMS Everolimus
Immunoassay Calibrator(QMS Everolimus
Immunoassay Calibrator Set)-The QMS
Everolimus Calibrator set is intended for use in
calibration of the QMS Everolimus assay.

983 IMP/IVD/2020/000420 Bio-Rad Kallestad Crithidia luciliae, 4 Well Kit, 24 CDSCO Class B
Laboratories (India) Tests(Kallestad Crithidia luciliae, 4 Well Kit, 24
Private Limited Tests)-An indirect fluorescent antibody procedure
for the detection and semi-quantitation of human
native nDNA auto-antibodies.,Kallestad HEp-2, 12
Well Kit, 240 Tests(Kallestad HEp-2, 12 Well Kit,
240 Tests)-An indirect fluorescent antibody
procedure for the detection and semi-quantitation
of human auto-antibodies.,Kallestad HEp-2, 12
Well Kit, 60 Tests(Kallestad HEp-2, 12 Well Kit, 60
Tests)-An indirect fluorescent antibody procedure
for the detection and semi-quantitation of human
auto-antibodies.,Kallestad Mouse Stomach Kidney,
8 Well Kit, 48 Tests(Kallestad Mouse Stomach
Kidney, 8 Well Kit, 48 Tests)-An indirect fluorescent
antibody procedure for the detection and semi-
quantitation of human auto-antibodies.,Kallestad
HEp-2, 6 Well Kit, 48 Tests(Kallestad HEp-2, 6
Well Kit, 48 Tests)-An indirect fluorescent antibody
procedure for the detection and semi-quantitation
of human auto-antibodies.,Kallestad Crithidia
luciliae, 8 Well Kit, 48 Tests(Kallestad Crithidia
luciliae, 8 Well Kit, 48 Tests)-An indirect
fluorescent antibody procedure for the detection
and semi-quantitation of human native nDNA auto-
antibodies.

984 IMP/IVD/2020/000421 HEALTH ARX DiaPlexQ™ Novel Coronavirus (2019-nCoV) CDSCO Class C
TECHNOLOGIES Detection Kit(SolGent Co., Ltd.)-DiaPlexQ™ Novel
PRIVATE LIMITED Coronavirus (2019-nCoV) Detection Kit is a real-
time RT-PCR test intended for the presumptive
SARS-CoV-2 in respiratory specimens such as
nasopharyngeal swab or oropharyngeal swab or
sputum from individuals suspected of COVID-19
that meet the CDC SARS-CoV-2 clinical criteria.
Results are for the presumptive detection and
identification of SARS-CoV-2 RNA. The SARS-
CoV-2 RNA is generally detectable in respiratory
specimens during the acute phase of infection.
Positive results are indicative of active infection
with SARS-CoV -2 but do not rule out bacterial
infection or co-infection with other viruses. Basic
principal of this kit is Real-time PCR method,
which is able to detect specific target gene into
total RNA. This is a OneStep Multiplex RT-qPCR
based detection with high-specificity & is intended
for use by trained clinical laboratory professionals.
985 IMP/IVD/2020/000422 PREMAS LIFE NX-48S Viral NA Kit(NX-48S Viral NA Kit)-A CDSCO Class C
SCIENCES PVT. reagent for extracting specific genes (DNA, RNA)
LTD for genetic testing in human-derived specimens
986 IMP/IVD/2020/000423 Almighty Techserv Viral transmission media-Virus specimen collection CDSCO Class A
tube with swabs

987 IMP/IVD/2020/000424 Abbott Healthcare Prealbumin Calibrator(Prealbumin Calibrator)-For CDSCO Class B

Pvt. Ltd. use in the calibration of the Prealbumin
assay.,Specific Proteins Multiconstituent
Calibrator(Specific Proteins Multiconstituent
Calibrator)-For use in the calibration of the
Immunoglobulin A (IgA), Immunoglobulin G (IgG),
Immunoglobulin M (IgM), Complement C3 (C3),
Complement C4 (C4), Haptoglobin, and
Transferrin assays.

988 IMP/IVD/2020/000425 Hotgen Biotech Myoglobin (MYO) test (Up-converting Phosphor CDSCO Class B
India Private Technology)-Intended for quantitative
Limited measurement of human cardiac Myoglobin (MYO)
in serum or plasma by a combination of Up-
Converting Phosphor Technology (UPT) employing
immunochromatography as an aiding tool for
myocardial infarction (AMI) risk
assessment.,Lipoprotein-associated
phospholipase A2 quantitative test(Enzyme-Linked
Immunosorbent Assay)-Intended for in-vitro
quantitative determination of the concentration of
Lipoprotein-associated phospholipase A2 in
human plasma sample. Study indicates that Lp-
PLA2 can be used for evaluating atherosclerosis
risk.,Anti-cyclic citrullinated peptide test (Up-
converting Phosphor Technology)-Intended for
quantitative measurement of human Anti-CCP in
serum employing a combination of Up-Converting
Phosphor Technology (UPT) and
immunochromatography as an aiding diagnostic
tool for Rheumatoid Arthritis.,Anti-Mullerian
Hormone test (Enzyme-Linked Immunosorbent
Assay)-Intended for in-vitro quantitative
determination of the concentration of anti-Mullerian
hormone in human serum sample, mainly used for
clinical diagnosis of ovarian reserve fuction.,Anti-
Mullerian Hormone test (Up-converting Phosphor
Technology)-Intended for in vitro quantitative
measurement of Anti Mullerian Hormone (AMH) in
human serum. it is mainly used for the auxiliary
judgment of female ovarian reserve
function.,Lipoprotein-associated Phospholipase A2
test(Chemiluminescence Immunoassay)-Intended
for the in vitro quantitative determination of the
Lipoprotein-associated phospholipase A2 (Lp-
PLA2) in human serum, plasma, and whole blood.

LP-PLA2 values are used to assess the risk of
atherosclerosis for patient.,Anti-cyclic citrullinated
peptide Rapid Test (Colloidal gold)-Intended for
semi-quantitative measurement of human anti-
cyclic citrullinated peptide antibody (Anti-CCP) in
serum and plasma employing colloidal gold
diagnosis of rheumatoid arthritis (RA) .,25-hydroxy
- vitamin D test (Chemiluminescence
Immunoassay)-Intended for the in vitro quantitative
determination of the 25-OH -VD in human serum,
plasma, and whole blood. 25-OH-VD values are
used to assist in diagnosis of the risk of Vitamin D
deficiency diseases etc.,Anti-cyclic citrullinated
peptide test (Enzyme-Linked ImmunoSorbent
Assay)-Intended for in-vitro quantitative
determination of the concentration of Anti-cyclic
citrullinated peptide (Anti-CCP) in human serum or
plasma sample, mainly used for clinical diagnosis
of rheumatoid arthritis(RA).,Myoglobin test
(Chemiluminescence Immunoassay)-Intended for
the in vitro quantitative determination of myoglobin
(MYO) in human serum, plasma, and whole blood.
MYO values are used to assist in diagnosis of
myocardial infarction (MI).,Creatine kinase mb
for the in vitro quantitative determination of the MB
isoenzyme of creatine kinase (CK-MB) in human
serum, plasma, and whole blood. CK-MB values
are used to assist in diagnosis of myocardial
infarction (MI), myopathy, etc.,Fetal Fibronectin
rapid test (Colloidal Gold)-Intended for qualitative
determination of human fetal fibronectin (fFN) in
cervicovaginal secretions employing colloidal gold
immunochromatography as an aiding tool for risk
estimation of preterm labor.,Creatine kinase mb

(CK-MB) test (Up-converting Phosphor
Technology)-Intended for quantitative
measurement of human cardiac creatine kinase
MB (CK-MB) in serum and plasma by a
combination of Up-Converting Phosphor
Technology (UPT) employing
immunochromatography as an aiding tool for early
diagnosis of Myocardial infarction and viral
myocarditis.,Lipoprotein-associated phospholipase
A2 test (Up-converting Phosphor Technology)-
Intended for quantitative measurement of human
lipoprotein associated phospholipase A2 (Lp-
PLA2) in plasma by a combination of Up-
Converting Phosphor Technology (UPT) employing
immunechromatography as an aiding tool for risk
stratification of atherosclerosis.,Free Thyroxine
test (Chemiluminescence Immunoassay)-Intended
for the in vitro quantitative determination of Free
Tyroxine in human serum and plasma.,Free
Triiodothyronine test (Chemiluminescence
determination of Free Triiodothyronine in human
serum and plasma.,Thyroid-stimulating Hormone
for the in vitro quantitative determination of
thyrotropin in human serum and plasma.,Thyroxine
for the in vitro quantitative determination of total
thyroxine in human serum and
plasma.,Triiodothyronine test (Chemiluminescence
determination of total triiodothyronine in human
serum and plasma.,Luteinizing Hormone test
the in vitro quantitative determination of Luteinizing
Hormone in human serum and plasma.,Prolactin

Prolactin in human serum and plasma.,Follicle-
stimulating hormone test (Chemiluminescence
determination of follicle-stimulating hormone in
human serum and plasma.,Anti-Mullerian hormone
for the in vitro quantitative determination of AMH in
human serum. The result obtained with the assay
is used as an aid in the assessment of ovarian
reserve.,Testosterone test (Chemiluminescence
Immunoassay)(Testosterone test
(Chemiluminescence Immunoassay))-Testosterone
assay is intended for the in vitro quantitative
determination of testosterone in human serum,
plasma. The result obtained with the assay is used
to assist in the diagnosis of related diseases with
abnormal testosterone levels.,Gastrin-17 test
(Chemiluminescence Immunoassay)(Gastrin-17
test (Chemiluminescence Immunoassay))-Gastrin-
17 (G-17) assay is intended for the in vitro
quantitative determination of G-17 in human serum
and plasma. The result obtained with the assay
can reflect the mucosal histology of various types
of gastritis and determine whether there is gastric
mucosal atrophy, and can be used to monitor the
therapeutic effect of non-atrophic
gastritis.,Progesterone test (Chemiluminescence
Immunoassay)(Progesterone test
(Chemiluminescence Immunoassay))-
Progesterone assay is intended for the in vitro
quantitative determination of progesterone in
human serum, plasma. The result obtained with
the assay is used to assist in fertility diagnosis of
the detection of ovulation and assessment of the

luteal phase,Estradiol test (Chemiluminescence
Immunoassay)(Estradiol test (Chemiluminescence
Immunoassay))-Estradiol assay is intended for the
in vitro quantitative determination of Estradiol in
human serum, plasma. The result obtained with
the assay is used to assist in the diagnosis of
ovarian disease,Serum amyloid A protein (SAA)
test (Up-converting Phosphor Technology )(Serum
amyloid A protein (SAA) test (Up-converting
Phosphor Technology ))-This kit is used for the in
vitro quantitative determination of human Serum
amyloid A protein (SAA) in serum, plasma and
whole blood. It is used to detect the content of
amyloid A in the sample, mainly as a non-specific
inflammation indicator,Collagen Type IV (CIV) test
(Up-converting phosphor technology) (Collagen
Type IV (CIV) test (Up-converting phosphor
technology) )-This kit is used for the in vitro
quantitative determination of collagen type IV(CIV)
in serum or plasma. Clinicially, it is used to
auxiliary diagnose the liver fibrosis. ,Hyaluronic
Acid (HA) test (Up-converting phosphor
technology) (Hyaluronic Acid (HA) test (Up-
converting phosphor technology) )-This kit is used
hyalutonic acid (HA) in serum or plasma.
Clinicially, it is used to auxiliary diagnose the liver
fibrosis. ,Laminin (LN) test (Up-converting
phosphor technology) (Laminin (LN) test (Up-
converting phosphor technology) )-This kit is used
Laminin (LN) in serum or plasma. Clinicially, it is
used to auxiliary diagnose the liver fibrosis.
,Procollagen III N-terminal peptide test (Up-
converting Phosphor Technology) (Procollagen III
N-terminal peptide test (Up-converting Phosphor

Technology) )-This kit is used for the in vitro
quantitative determination of Procollagen III N-
terminal peptide (PIII NP) in serum or plasma.
Clinicially, it is used to auxiliary diagnose the liver
fibrosis. ,Interleukin-6 test (Up-converting
Phosphor Technology )-Intended for quantitative
measurement of human Interleukin 6 (IL-6) in
serum by a combination of Up-converting
Phosphor Technology (UPT) employing
diagnosis of infection.,Interleukin-6 test
(Chemiluminescence Immunoassay )-Intended for
the in vitro quantitative determination of IL-6 in
human serum, plasma and whole blood. The result
obtained with the assay is used to assist in the
diagnosis of inflammation and an early alarm
signal of infection.

989 IMP/IVD/2020/000425 Hotgen Biotech Novel Coronavirus 2019-nCoV Antibody Test (Up- CDSCO Class C
India Private converting Phosphor Immunochromatographic
Limited Technology)(Novel Coronavirus 2019-nCoV
Antibody Test (Up-converting Phosphor
Immunochromatographic Technology))-whole
blood samples. It is only used as a supplementary
detection indicator for suspected cases of novel
coronavirus nucleic acid negative detection or in
conjunction with nucleic acid detection in
suspected cases. It cannot be used as a basis for
the diagnosis and exclusion of pneumonitis
infected by new coronavirus. It is not suitable for
screening of the general population,C reactive
protein/Serum amyloid A protein combo test (Up-
Converting Phosphor Technology )(C reactive
protein/Serum amyloid A protein combo test (Up-
Converting Phosphor Technology ))-This IVD kit
used for the in vitro quantitative determination of C
reactive protein/Serum amyloid A protein in human
serum and peripheral whole blood. Mainly as a
non-specific inflammation indicator.,High sensitive
Cardiac Troponin-I test (Chemiluminescence
determination of the Cardiac Troponin-I (cTnI) in
human serum, plasma, and whole blood. cTnI
values are used to assist in diagnosis of
myocardial infarction (MI).,N-terminal Pro-B-type
Natriuretic Peptide (NT-proBNP) test (Up-
quantitative measurement of human NT-pro BNP
in serum and plasma employing combination of
Up-Converting Phosphor Technology (UPT) and
tool for congestive heart failure
(CHF).,Procalcitonin test (Up-converting Phosphor
Technology)-Intended for quantitative

measurement of human procalcitonin (PCT) in
serum and plasma employing a combination of Up-
Converting Phosphor Technology (UPT) and
tool for severe bacterial infection and sepsis.,N-
terminal Pro-B-type Natriuretic Peptide Rapid Test
(Colloidal gold)-Intended for semi-quantitative
measurement of human N-terminal Pro B-type
Natriuretic Peptide (NT-proBNP) in serum or
plasma emplying colloidal gold
diagnosis of congestive heart failure (CHF)
.,Procalcitonin Rapid Test(Colloidal Gold)-Intended
for semi-quantitative measurement of human
procalcitonin (PCT) in serum and plasma
employing colloidal gold immunochromatography
as an aiding tool for diagnosis of severe bacterial
infection and sepsis.,C reactive Protein (CRP) test
(Up-converting Phosphor Technology)-Intended for
quantitative measurement of human C reactive
protein (CRP) in serum or plasma by a
combination of Up- Converting Phosphor
inflammatory conditions and risk stratification for
cardiac events.,D-dimer test (Up-converting
Phosphor Technology)-Intended for quantitative
measurement of D-dimer in plasma by a
combination of Up-Converting Phosphor
diagnostic criteria of acute pulmonary embolism
and deep vein thrombosis.,C-reactive protein
for the in vitro quantitative determination of the C-
reactive protein in human serum, plasma, and

whole blood. C-reactive protein values are used to
the index of Nonspecific inflammation,
etc.,Procalcitonin test(Chemiluminescence
determination of the Procalcitonin(PCT) in human
serum, plasma, and whole blood. Procalcitonin
values are used to assist in diagnosis of bacterial
infectious diseases etc.,N-terminal Pro-B-type
Natriuretic Peptide test (Chemiluminescence
determination of N-terminal Pro-B-type Natriuretic
Peptide (NT-proBNP) in human serum, plasma,
and whole blood. NT-proBNP values are used to
assist in diagnosis of cardiac failure.,D-Dimer Test
the in vitro quantitative determination of D-Dimer in
human plasma and whole blood. D-Dimer values
are used to assist in diagnosis of venous
thrombosis and DIC, and monitor prognosis of
thrombolytic therapy.,Cardiac Troponin- I test(Up-
quantitative measurement of human cTnI in serum
or plasma by a combination of Up-Converting
Phosphor Technology (UPT) employing
diagnosis of heart attack.

990 IMP/IVD/2020/000426 Invitrogen Sequence Detection Primer(Applied Biosystems)- CDSCO Class C

Bioservices India Sequence detection primers are unlabeled primers
Pvt. Ltd. that can be used with TaqMan probes or SYBR
Green dye for your real-time PCR research
applications,TaqMan™ MGB Probe(Applied
Biosystems)-Applied Biosystems TaqMan MGB
(minor groove binder) probes are dual-labeled
probes used for real-time PCR applications using
TaqMan chemistry.,TaqPath™ COVID-19 CE-IVD
RT-PCR Kit(Applied Biosystems)-TaqPath™
COVID-19 CE-IVD RT-PCR Kit contains the
reagents and controls for a real-time reverse
transcription polymerase chain reaction (RT-PCR)
test intended for the qualitative detection of nucleic
acid from SARS-CoV-2 in nasopharyngeal swab,
nasopharyngeal aspirate, and bronchoalveolar
lavage (BAL) specimens from individuals
suspected of COVID-19.Additional information in
the IFU except indented use i.e. Addition of
instruction for preparing RT-PCT Reaction on ice
,added GDPR etc. is acknowledged.
991 IMP/IVD/2020/000431 Iris Hightech Private SARS CoV 2 RAPID ANTIBODY TEST/ COVID 19 CDSCO Class C
Limited TEST-Our “CoV-2 RAPID TEST” is intended for the
detection of “Corona 2019” / SARS-CoV-2 virus -
antibodies. Two biomarkers are used, one is IgM,
the other is IgG. The rapid test is an in-vitro
diagnostic immunochromatographic assay
intended for the qualitative detection of the
concentration of IgM / IgG antibodies in capillary or
whole blood or serum. Measurements of IgM / IgG
antibodies are to be used in the diagnosis and
treatment of patients who have been exposed to
the SARS-CoV-2 virus, as well as assist in
preventing the spread of the disease.

992 IMP/IVD/2020/000433 INBIOS INDIA Smart DetectTM SARS-CoV-2 rRT-PCR CDSCO Class C
Kit(Inbios)-Smart DetectTM SARS-CoV-2 rRT-PCR
Kit is a real-time RT-PCR test intended for the
qualitative detection of nucleic acid from severe
acute respiratory syndromerelated coronavirus 2
(SARS-CoV-2) in human nasopharyngeal swab,
anterior nasal swab and midturbinate nasal swab
specimens from individuals suspected of COVID-
19 by their healthcare provider.

993 IMP/IVD/2020/000434 Greiner Bio-one Blood Collection Tube(Vacuette)-VACUETTE CDSCO Class A

India Private Blood Collection Tubes Holders and Needles are
Limited used together as a system for the collection of
venous blood. VACUETTE tubes are used to
collect transport store and process blood for
testing serum plasma or whole blood in the clinical
laboratory and are for professional use.,Blood
Collection Tube(Vacuette )-VACUETTE Blood
Collection Tubes Holders and Needles are used
together as a system for the collection of venous
blood. VACUETTE tubes are used to collect
transport store and process blood for testing
serum plasma or whole blood in the clinical
laboratory and are for professional use. ,Blood
Collection Tube(MiniCollect)-To collect transport

separate and process capillary blood for testing
serum in the clinical laboratory.,Blood Collection
Tube(MiniCollect)-K2EDTA Tubes are non
evacuated blood collection devices used to collect
transport store and evaluate capillary blood
specimens for the following hematology
parameters: WBC RBC HGB HCT MCV MCH
MCHC Platelets RDW Lymphocytes Neutrophiles
Monocytes Eosinophils and Basophils.,Blood
Collection Tube(MiniCollect)-The MiniCollect 9NC
Coagulation Tube is intended for collection of
citrate anticoagulated whole blood samples for
coagulation assays,Blood Collection
Tube(MiniCollect)-MiniCollect TUBE Lithium
Heparin is intended for collect transport separate
and process capillary blood for testing plasma in
the clinical laboratory.,Urine Collection
Tube(Vacuette)-VACUETTE Urine Tubes Urine
Beakers and Urine Transfer Devices are used
together as a system for the collection transport
processing and testing of urine in the clinical
laboratory.,Urine Collection Tube (Vacuette )-
VACUETTE Urine Tubes Urine Beakers and Urine
Transfer Devices are used together as a system
for the collection transport processing and testing
of urine in the clinical laboratory. ,Urine Collection
Tube (Vacuette )-The VACUETTE Urine Count and
Culture Mannitol tube is a urine stabilization device
intended for collection transport and storage of
urine for bacterial and yeast culture. Urine samples
collected in the VACUETTE Urine Count and
Culture Mannitol tube can be stored at 20-25 C
(68-77 F) for up to 48 h prior to culture. This device
is intended for professional use only.,Blood

Collection Tube(VACUETTE SECONDARY Tube
MULTIPLEX PP)-VACUETTE SECONDARY Tubes
are used as a secondary container for aliquoting,
storing and transporting blood, blood components
and urine from the primary tube in the clinical
laboratory and for the analysis on laboratory
analysers. The choice of tube depends on the
analyser and the intended use.
994 IMP/IVD/2020/000434 Greiner Bio-one Virus Stabilization Tube(VACUETTE® Virus CDSCO Class B
India Private Stabilization Tube)-VACUETTE® Virus
Limited Stabilization Tubes are intended for the transport
and storage of nasopharyngeal and oropharyngeal
swab specimens. The product is to be used by
healthcare professionals for SARS-CoV-2 testing
only.

995 IMP/IVD/2020/000435 M/s. Ortho Clinical VITROS 3600 lmmunodiagnostic System Software CDSCO Class A
Diagnostics India Update(VITROS 3600 lmmunodiagnostic System
Private Limited Software Update)-For In Vitro Diagnostic and
Laboratory Professional use only. The VITROS
3600 Immunodiagnostic System Software update
is used to support the function of the VITROS
3600 Immunodiagnostic System for use in the in
vitro quantitative, semi-quantitative, and qualitative
measurement of a variety of analytes of clinical
interest, using VITROS Immunodiagnostic
Products Reagents.,VITROS 3600
lmmunodiagnostic System Software(VITROS 3600
lmmunodiagnostic System Software)-For In Vitro
Diagnostic and Laboratory Professional use only.
The VITROS 3600 Immunodiagnostic System
Software is used to support the function of the
VITROS 3600 Immunodiagnostic System for use
in the in vitro quantitative, semi-quantitative, and
qualitative measurement of a variety of analytes of
clinical interest, using VITROS Immunodiagnostic
Products Reagents.,VITROS 5, 1 FS Chemistry
System Software Update(VITROS 5, 1 FS
Chemistry System Software Update)-For In Vitro
Diagnostic and Laboratory Professional use. The
VITROS 5,1 FS Chemistry System Software
update is used to support the function of the
VITROS 5,1 FS Chemistry System is intended for
use in the in vitro quantitative, semi-quantitative,
and qualitative measurement of a variety of
analytes of clinical interest.,VITROS 5600
Integrated System Software Update(VITROS 5600
Integrated System Software Update)-For In Vitro
VITROS 5600 Integrated System Software Update
is used to support the function of the VITROS
5600 Integrated System is intended for use in the

in vitro quantitative, semi-quantitative, and
qualitative measurement of a variety of analytes of
clinical interest, using VITROS Chemistry Products
MicroSlides, VITROS Chemistry Products MicroTip
Reagents and VITROS Immunodiagnostic
Products Reagents.,VITROS 5600 Integrated
System Software(VITROS 5600 Integrated System
Software)-For In Vitro Diagnostic and Laboratory
Professional use. The VITROS 5600 Integrated
System Software is used to support the function of
the VITROS 5600 Integrated System is intended
for use in the in vitro quantitative, semi-
quantitative, and qualitative measurement of a
variety of analytes of clinical interest, using
VITROS Chemistry Products MicroSlides, VITROS
Chemistry Products MicroTip Reagents and
VITROS Immunodiagnostic Products
Reagents.,VITROS XT 7600 Integrated System
Software Update(VITROS XT 7600 Integrated
System Software Update)-For In Vitro Diagnostic
and Laboratory Professional use. The VITROS XT
7600 Integrated System Software update is used
to support the function of the VITROS XT 7600
Integrated System is intended for use in the in vitro
quantitative, semi-quantitative, and qualitative
interest, using VITROS Chemistry Products
MicroSlides, VITROS Chemistry Products MicroTip
Reagents and VITROS Immunodiagnostic
Products Reagents.,VITROS XT 3400 Chemistry
System Software(VITROS XT 3400 Chemistry
System Software)-For In Vitro Diagnostic and
Laboratory Professional use. The VITROS XT
3400 Chemistry System Software is used to
support the function of the VITROS XT 3400
Chemistry System is intended for use in the in vitro

quantitative measurement of a variety of analytes
of clinical interest, using VITROS Chemistry
Products MicroSlides.,VITROS XT 3400 Chemistry
System Software Update(VITROS XT 3400
VITROS XT 3400 Chemistry System Software
VITROS XT 3400 Chemistry System is intended
for use in the in vitro quantitative measurement of
a variety of analytes of clinical interest, using
VITROS Chemistry Products MicroSlides.,VITROS
4600 Chemistry System Software Update(VITROS
4600 Chemistry System Software Update)-For in
vitro diagnostic use only. The VITROS 4600
Chemistry System Software update is used to
support the function of the VITROS 4600
Chemistry System is intended for use in the in vitro
quantitative, semi-quantitative, and qualitative
interest,VITROS XT 7600 Integrated System
Software(VITROS XT 7600 Integrated System
Software)-For In Vitro Diagnostic and Laboratory
Professional use. The VITROS XT 7600 Integrated
System Software is used to support the function of
the VITROS XT 7600 Integrated System is
intended for use in the in vitro quantitative, semi-
variety of analytes of clinical interest, using
VITROS Chemistry Products MicroSlides, VITROS
Chemistry Products MicroTip Reagents and
VITROS Immunodiagnostic Products
Reagents.,VITROS ECi/ECiQ lmmunodiagnostic
System Software(VITROS ECi/ECiQ
lmmunodiagnostic System Software)-For In Vitro

VITROS ECi/ECiQ Immunodiagnostic System
VITROS® ECi/ECiQ Immunodiagnostic System
perform random access, batch, and STAT
immunodiagnostic assays on human fluid
specimens. The system uses chemiluminescence
detection technology to provide accurate and
reliable results for heterogeneous assays. All
reactions for a single quantitative, semi-
quantitative, and qualitative measurement take
place within a coated well.,VITROS 4600
Chemistry System Software(VITROS 4600
Chemistry System Software)-For in vitro diagnostic
use only. The VITROS 4600 Chemistry System
VITROS 4600 Chemistry System is intended for
use in the in vitro quantitative, semi-quantitative,
and qualitative measurement of a variety of
analytes of clinical interest.,VITROS 350/250
Chemistry System Software(VITROS 350/250
Chemistry System Software)-For In Vitro
VITROS 350/250 Chemistry System Software is
used to support the function of the VITROS
250/350 Chemistry System performs discrete
clinical tests on serum, urine, and cerebral spinal
fluid specimens. Methodologies include
colorimetric (CM), potentiometric (PM), rate (RT),
and immuno-rate (IR) tests using multi-layered
VITROS Slides.,VITROS 350/250 Chemistry
System Software Update(VITROS 350/250
VITROS 350/250 Chemistry System Software
VITROS 250/350 Chemistry System performs

discrete clinical tests on serum, urine, and cerebral
spinal fluid specimens. Methodologies include
VITROS Slides.,VITROS 350/250 Chemistry
System Software Update(VITROS 350/250
VITROS 350/250 Chemistry System Software
VITROS 250/350 Chemistry System performs
discrete clinical tests on serum, urine, and cerebral
spinal fluid specimens. Methodologies include
VITROS Slides.,VITROS 5,1 FS Chemistry
System Software(VITROS 5,1 FS Chemistry
System Software)-For In Vitro Diagnostic and
Laboratory Professional use. The VITROS 5,1 FS
Chemistry System Software is used to support the
function of the VITROS 5,1 FS Chemistry System
is intended for use in the in vitro quantitative, semi-
variety of analytes of clinical interest. ,VITROS
350/250 Chemistry System Software(VITROS
350/250 Chemistry System Software)-For In Vitro
VITROS 350/250 Chemistry System Software is
used to support the function of the VITROS
250/350 Chemistry System performs discrete
clinical tests on serum, urine, and cerebral spinal
fluid specimens. Methodologies include
VITROS Slides.,VITROS ECi/ECiQ
lmmunodiagnostic System Software

Update(VITROS ECi/ECiQ lmmunodiagnostic
System Software Update)-For In Vitro Diagnostic
and Laboratory Professional use. The VITROS
ECi/ECiQ Immunodiagnostic System Software
VITROS® ECi/ECiQ Immunodiagnostic System
perform random access, batch, and STAT
immunodiagnostic assays on human fluid
specimens. The system uses chemiluminescence
detection technology to provide accurate and
reliable results for heterogeneous assays. All
reactions for a single quantitative, semi-
quantitative, and qualitative measurement take
place within a coated well.

996 IMP/IVD/2020/000435 M/s. Ortho Clinical VITROS Immunodiagnostic Products Anti‑SARS- CDSCO Class C
Diagnostics India CoV-2 Total Controls-For in vitro diagnostic and
Private Limited Laboratory Professional use. For use in monitoring
the performance of the Suitable VITROS Systems
when used for the determination of antibodies to
SARS-CoV-2.,VITROS Immunodiagnostic
Products Anti-SARS-CoV-2 Total Calibrator-For in
vitro diagnostic and Laboratory Professional use.
The VITROS Immunodiagnostic Products Anti-
SARS-CoV-2 Total Reagent Pack test when used
in combination with the VITROS Immunodiagnostic
Products Anti-SARS-CoV-2 Total Calibrator is for
the qualitative measurement of total antibody
(including IgG and IgM) to SARS-CoV-2 in human
serum and plasma (K2 EDTA) samples from
patients suspected of COVID-19 by a healthcare
provider, using suitable VITROS
Systems.,VITROS Immunodiagnostic Products
Anti-SARS-CoV-2 Total Reagent Pack-For in vitro
diagnostic and Laboratory Professional use. The
VITROS Immunodiagnostic Products Anti-SARS-
CoV-2 Total Reagent Pack test when used in
combination with the VITROS Immunodiagnostic
Products Anti-SARS-CoV-2 Total Calibrator is for
the qualitative measurement of total antibody
(including IgG and IgM) to SARS-CoV-2 in human
serum and plasma (K2 EDTA) samples from
patients suspected of COVID-19 by a healthcare
provider, using suitable VITROS Systems.

997 IMP/IVD/2020/000439 DIAGNOSTIC ZENA MAX COVID-19 qPCR Detection Kit-This CDSCO Class C
BIOSYSTEMS assay is an in-vitro PCR test for the qualitative
(INDIA) identification of Corona virus 2019 COVID-19 RNA
in human samples such as nasopharyngeal swabs
or bronchoalveolar lavage (BAL). It is based on the
hydrolysis probe detection method and is a highly
sensitive one-step RT-qPCR kit.
998 IMP/IVD/2020/000441 Becton Dickinson BD BBL Coagulase Plasma, Rabbit with EDTA(BD CDSCO Class B
India Private BBL Coagulase Plasma, Rabbit with EDTA)-BD
Limited BBL Coagulase Plasma, Rabbit with EDTA are
used to qualitatively determine the pathogenicity of
staphylococci using the direct tube method.,BD
BBL Coagulase Plasma, Rabbit(BD BBL
Coagulase Plasma, Rabbit)-BD BBL™ Coagulase
Plasma, Rabbit are used to qualitatively determine
the pathogenicity of staphylococci using the direct
tube method.

999 IMP/IVD/2020/000441 Becton Dickinson BD Difco™ Salmonella O Antiserum Group F CDSCO Class C
India Private Factor 11(BD Difco™ Salmonella O Antiserum
Limited Group F Factor 11)-BD Difco™ Salmonella O
Antisera are used in slide agglutination tests for
the identification of Salmonella by somatic (O)
antigens.,BD Difco™ Salmonella O Antiserum
Group I Factor 16(BD Difco™ Salmonella O
Antiserum Group I Factor 16)-BD Difco™
Salmonella O Antisera are used in slide
agglutination tests for the identification of
Salmonella by somatic (O) antigens.,BD Difco™
Salmonella H Antiserum Poly C(BD Difco™
Salmonella H Antiserum Poly C)-BD Difco
Salmonella H Antisera are used in tube
Salmonella by flagellar (H) antigens.,BD Difco™
Salmonella H Antiserum Poly D(BD Difco™
Salmonella H Antiserum Poly D)-BD Difco
Salmonella H Antiserum eh(BD Difco™ Salmonella
H Antiserum eh)-BD Difco Salmonella H Antisera
are used in tube agglutination tests for the
identification of Salmonella by flagellar (H)
antigens.,BD Difco™ Salmonella H Antiserum
k(BD Difco™ Salmonella H Antiserum k)-BD Difco
Salmonella H Antiserum z(BD Difco™ Salmonella
H Antiserum z)-BD Difco Salmonella H Antisera
antigens.,BD Difco™ Listeria O Antiserum Poly
Serotypes 1, 4(BD Difco™ Listeria O Antiserum

Poly Serotypes 1, 4)-BD Difco™ Listeria O
Antisera Types 1, 4 and Poly are used for
identifying Listeria monocytogenes in the slide
agglutination test. BD Difco Listeria O Antigens
Types 1 and 4 (Slide) are used as positive controls
in the slide agglutination test,BD Difco™
Bordetella pertussis Antiserum(BD Difco™
Bordetella pertussis Antiserum)-BD Difco™
Bordetella Pertussis Antiserum and BD Difco
Bordetella Parapertussis Antiserum are
recommended for use in slide agglutination tests
for the identification of Bordetella pertussis and
Bordetella parapertussis. BD Difco Bordetella
Pertussis Antigen is used to demonstrate a
positive quality control test in the slide
agglutination test.,BD Difco™ Salmonella H
Antiserum Poly A-Z(BD Difco™ Salmonella H
Antiserum Poly A-Z)-BD Difco Salmonella H
Antisera are used in tube agglutination tests for the
antigens.,BD Difco™ vibrio cholera Antiserum
Inaba(BD Difco™ vibrio cholera Antiserum Inaba)-
BD Difco™ Vibrio Cholerae antisera are
for the identification and serotyping of Vibrio
cholerae.,BD Difco™ vibrio cholera Antiserum
Ogawa(BD Difco™ vibrio cholera Antiserum
Ogawa)-BD Difco™ Vibrio Cholerae antisera are
cholerae,BD Difco™ vibrio cholera Antiserum Poly,
Hikojima, Inaba, Ogawa(BD Difco™ vibrio cholera
Antiserum Poly, Hikojima, Inaba, Ogawa)-BD
Difco™ Vibrio Cholerae antisera are

cholerae.,BD Difco™ Salmonella H Antiserum
Single Factor 2(BD Difco™ Salmonella H
Antiserum Single Factor 2)-BD Difco Salmonella H
Group O Factor 35(BD Difco™ Salmonella O
Antiserum Group O Factor 35)-BD Difco™
Salmonella O Antiserum Poly A (BD Difco™
Salmonella O Antiserum Poly A)-BD Difco™
Salmonella by somatic (O) antigens,BD Difco™
Salmonella O Antiserum Poly B(BD Difco™
Salmonella O Antiserum Poly B)-BD Difco™
Salmonella O Antiserum Poly C(BD Difco™
Salmonella O Antiserum Poly C)-BD Difco™

Salmonella O Antiserum Poly D(BD Difco™
Salmonella O Antiserum Poly D)-BD Difco™
Salmonella H Antiserum Poly A(BD Difco™
Salmonella H Antiserum Poly A)-BD Difco
Salmonella H Antiserum Poly B(BD Difco™
Salmonella H Antiserum Poly B)-BD Difco
Salmonella H Antiserum Single Factor m(BD
Difco™ Salmonella H Antiserum Single Factor m)-
BD Difco Salmonella H Antisera are used in tube
Salmonella O Antiserum Poly G(BD Difco™
Salmonella O Antiserum Poly G)-BD Difco™
Salmonella O Antiserum Factor 4(BD Difco™
Salmonella O Antiserum Factor 4)-BD Difco™

Shigella Antiserum Poly Group A1(BD Difco™
Shigella Antiserum Poly Group A1)-BD Difco™
Shigella Antisera Poly are used for the
identification of Shigella species by the slide
agglutination test.,BD Difco™ Shigella Antiserum
Poly Group C1(BD Difco™ Shigella Antiserum
Poly Group C1)-BD Difco™ Shigella Antisera Poly
are used for the identification of Shigella species
by the slide agglutination test.,BD Difco™ Shigella
Antiserum Poly Group C2(BD Difco™ Shigella
Antiserum Poly Group C2)-BD Difco™ Shigella
Antisera Poly are used for the identification of
Shigella species by the slide agglutination test.,BD
Difco™ Salmonella O Antiserum Factor 12(BD
Difco™ Salmonella O Antiserum Factor 12)-BD
Difco™ Salmonella O Antisera are used in slide
Salmonella O Antiserum Factor 2 (BD Difco™
Salmonella O Antiserum Factor 2 )-BD Difco™

Salmonella O Antiserum Group E Factors
1/3/10/15/19/34(BD Difco™ Salmonella O
Antiserum Group E Factors 1/3/10/15/19/34)-BD
Salmonella H Antiserum a(BD Difco™ Salmonella
H Antiserum a)-BD Difco Salmonella H Antisera
antigens.,BD Difco™ Salmonella H Antiserum I(BD
Difco™ Salmonella H Antiserum I)-BD Difco
Neisseria Meningitidis Antiserum Group X(BD
Difco™ Neisseria Meningitidis Antiserum Group
X)-BD Difco™ Neisseria Meningitidis Antisera are
for serotyping Neisseria meningitidis.,BD Difco™
Salmonella H Antiserum G Complex(BD Difco™
Salmonella H Antiserum G Complex)-BD Difco
Salmonella by flagellar (H) antigens,BD Difco™
Salmonella H Antiserum 1 Complex(BD Difco™
Salmonella H Antiserum 1 Complex)-BD Difco

Salmonella H Antiserum b(BD Difco™ Salmonella
H Antiserum b)-BD Difco Salmonella H Antisera
antigens.,BD Difco™ Shigella Antiserum Poly
Group D(BD Difco™ Shigella Antiserum Poly
Group D)-BD Difco™ Shigella Antisera Poly are
used for the identification of Shigella species by
the slide agglutination test.,BD Difco™ Shigella
Antiserum Poly Group C (BD Difco™ Shigella
Antiserum Poly Group C )-BD Difco™ Shigella
Antisera Poly are used for the identification of
Shigella species by the slide agglutination test.,BD
Difco™ Shigella Antiserum Poly Group A (BD
Difco™ Shigella Antiserum Poly Group A )-BD
Difco™ Shigella Antisera Poly are used for the
identification of Shigella species by the slide
agglutination test.,BD Difco™ Salmonella H
Antiserum d(BD Difco™ Salmonella H Antiserum
d)-BD Difco Salmonella H Antisera are used in
tube agglutination tests for the identification of
Salmonella H Antiserum c(BD Difco™ Salmonella
H Antiserum c)-BD Difco Salmonella H Antisera
antigens.,BD Difco™ Alkalescens-Dispar
Antiserum Poly Contains Types 1-4(BD Difco™
Alkalescens-Dispar Antiserum Poly Contains
Types 1-4)-BD Difco Alkalescens-Dispar Antiserum
Poly is used for the identification of Alkalescens-
Dispar Group of microorganisms by the slide
agglutination test.,BD Difco™ Shigella Antiserum
Poly Group B(BD Difco™ Shigella Antiserum Poly
Group B)-BD Difco™ Shigella Antisera Poly are
used for the identification of Shigella species by

the slide agglutination test.,BD Difco™ Neisseria
Meningitidis Antiserum Group Y(BD Difco™
Neisseria Meningitidis Antiserum Group Y)-BD
Difco™ Neisseria Meningitidis Antisera are
for serotyping Neisseria meningitidis,BD Difco™
Salmonella O Antiserum Group A Factors
1,2,12(BD Difco™ Salmonella O Antiserum Group
A Factors 1,2,12)-BD Difco™ Salmonella O
Group C2 Factors 6, 8(BD Difco™ Salmonella O
Antiserum Group C2 Factors 6, 8)-BD Difco™
Salmonella O Antiserum Group D1 Factors
1,9,12(BD Difco™ Salmonella O Antiserum Group
D1 Factors 1,9,12)-BD Difco™ Salmonella O
Group E1 Factor 3,10(BD Difco™ Salmonella O
Antiserum Group E1 Factor 3,10)-BD Difco™
Salmonella by somatic (O) antigens.,BD Difco™ E.
Coli O Antiserum 0157(BD Difco™ E. Coli O
Antiserum 0157)-BD Difco™ E. Coli O Antiserum
O157 and BD Difco E. Coli H Antiserum H7 are
used in tube agglutination tests for identifying
Escherichia coli O157:H7.,BD Difco™ Salmonella
O Antiserum Group B Factors 1,4,12,27(BD
Difco™ Salmonella O Antiserum Group B Factors
1,4,12,27)-BD Difco™ Salmonella O Antisera are

used in slide agglutination tests for the
identification of Salmonella by somatic (O)
Group C3 factors (8), 20(BD Difco™ Salmonella O
Antiserum Group C3 factors (8), 20)-BD Difco™
Salmonella O Antiserum Group D2 factors (9),
46(BD Difco™ Salmonella O Antiserum Group D2
factors (9), 46)-BD Difco™ Salmonella O Antisera
are used in slide agglutination tests for the
Group E3 Factors 3,15, 34(BD Difco™ Salmonella
O Antiserum Group E3 Factors 3,15, 34)-BD
Salmonella O Antiserum Group E4 Factors 1, 3,
19(BD Difco™ Salmonella O Antiserum Group E4
Factors 1, 3, 19)-BD Difco™ Salmonella O
Group G Factors 13, 22, 23, 36, 37(BD Difco™
Salmonella O Antiserum Group G Factors 13, 22,
23, 36, 37)-BD Difco™ Salmonella O Antisera are
used in slide agglutination tests for the
antigens,BD Difco™ Salmonella O Antiserum
Group M Factor 28(BD Difco™ Salmonella O
Antiserum Group M Factor 28)-BD Difco™
Salmonella by somatic (O) antigens.,BD Difco™ E.

Coli H Antiserum H7(BD Difco™ E. Coli H
Antiserum H7)-BD Difco™ E. Coli O Antiserum
O157 and BD Difco E. Coli H Antiserum H7 are
used in tube agglutination tests for identifying
Escherichia coli O157:H7.,BD Difco™ Neisseria
Meningitidis Antiserum Group A(BD Difco™
Neisseria Meningitidis Antiserum Group A)-BD
Neisseria Meningitidis Antiserum Group C(BD
C)-BD Difco™ Neisseria Meningitidis Antisera are
Salmonella O Antiserum Poly A-I & Vi(BD Difco™
Salmonella O Antiserum Poly A-I & Vi)-BD Difco™
Neisseria Meningitidis Antiserum Poly Contains
Group A,B,C,D(BD Difco™ Neisseria Meningitidis
Antiserum Poly Contains Group A,B,C,D)-BD
for serotyping Neisseria meningitidis.,BD Difco™
Neisseria Meningitidis Antiserum Group W135(BD
W135)-BD Difco™ Neisseria Meningitidis Antisera
are recommended for use in slide agglutination
tests for serotyping Neisseria meningitidis,BD
Difco™ Haemophilus Influenzae Antiserum Type
b(BD Difco™ Haemophilus Influenzae Antiserum
Type b)-BD Difco™ Haemophilus Influenzae
Antisera are recommended for use in slide
agglutination tests for serotyping Haemophilus

influenzae.,BD Difco™ Salmonella Vi
Antiserum(BD Difco™ Salmonella Vi Antiserum)-
BD Difco Salmonella Vi Antiserum is used in slide
Salmonella Vi.

1000 IMP/IVD/2020/000442 Kopran Auto-Chemistry Analyzer - CST240 Plus(Dirui)-The CDSCO Class A

Laboratories product is a fully automated instrument for
Limited quantitative analysis of chemical components in
human samples (including serum, plasma, urine,
cerebrospinal fluid, hydrothorax and ascites),
which can assist in the diagnosis of normal people
and patients with related diseases.,Automatic
Hematology Analyzer – BF 6900(Dirui)-The
Analyzer can provide quantitative analysis results
of 25 parameters. Applicable scope of the
Analyzer: It can count the number of red blood
cells and platelets in blood sample with impedance
method, test the hemoglobin concentration with
colorimetric method, get the total number and have
five-classification of the white blood cells with
semiconductor laser flow cytometry and calculate
hemocyte related parameters.,Automatic
Hematology Analyzer – BF 6800(Dirui)-The
instrument can test quantitative analysis result of
24 blood parameters and 10 research parameters.
Instrument is connected with computer to conduct
operations. The scope of the product: BF Series
Automatic Hematology Analyzer is an in vitro
diagnostic medical instrument used by
professionals for screening. It is used for testing
red blood cell (RBC), platelet (PLT), white blood
cell (WBC) number and volume distribution and
concentration of hemoglobin, and it offers
scattergram of white blood cell to help clinical
diagnosis.,Urinalysis Hybrid - FUS- 3000
Plus(Dirui)-The Analyzer can be used with the
urine test strips (product model: FUS-10 II, FUS-11
II, FUS-11MA II, FUS-12MA II, FUS-13Cr II, and
FUS-14Ca II) to finish the routine analysis of urine.
Applying high intensity five-wavelength cold light
source test technology, the Analyzer has long

service life, high accuracy, sensitivity, specificity
and stability and can correct the effects to test
results brought by pH value, hematuresis and
abnormally dyed sample.,Urinalysis Hybrid – FUS
- 2000(Dirui)-The instrument can perform routine
urine analysis with reagent strips for urinalysis
(H10-800, H11-800, H11- 800MA, H12-800MA,
H13-800Cr, H14-800Ca, FUS- 10, FUS-11, FUS-
11MA, FUS-12MA, FUS-13Cr, and FUS-
14Ca),Auto-Chemistry Analyzer - CS- 680(Dirui)-
The product is a fully automated instrument for
quantitative analysis of chemical components in
human samples (including serum, plasma, urine,
cerebrospinal fluid, hydrothorax and ascites),
which can assist in the diagnosis of normal people
and patients with related diseases,Auto-Chemistry
Analyzer - CS- 480(Dirui)-The product is a fully
automated instrument for quantitative analysis of
chemical components in human samples
(including serum, plasma, urine, cerebrospinal
fluid, hydrothorax and ascites), which can assist in
the diagnosis of normal people and patients with
related disease
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5/19/23, 5:59 PM MD - Medical Devices

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907 IMP/IVD/2020/000317 Aadivighnesh Real-Time PCR Coronavirus (SARS-CoV-2) CDSCO Class C

S. License Approving Device

909 IMP/IVD/2020/000320 HUMOLE Allplex 2019-nCoV Assay(Allplex)-Allplex 2019- CDSCO Class C

910 IMP/IVD/2020/000321 Instrumentation HemosIL AcuStar Triggers(HemosIL)-Catalyst and CDSCO Class B

S. License Approving Device

S. License Approving Device

S. License Approving Device

S. License Approving Device

912 IMP/IVD/2020/000322 KDH PNEUMOSLIDE IgM(PNEUMOSLIDE IgM CDSCO Class B

913 IMP/IVD/2020/000322 KDH COVID‐19 VIRCLIA IgM+IgA MONOTEST(Vircell)- CDSCO Class C

S. License Approving Device

S. License Approving Device

917 IMP/IVD/2020/000330 BIOHOUSE IgM-IgG Rapid Test(COVID-19)-BioMedomics CDSCO Class C

S. License Approving Device

S. License Approving Device

920 IMP/IVD/2020/000337 Instrumentation HemosIL AcuStar ADAMTS13 Activity(HemosIL)- CDSCO Class C

921 IMP/IVD/2020/000338 Immunoshop India Immunofluorescence Analyzer (Lifotronic)-FA-160 CDSCO Class A

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S. License Approving Device

923 IMP/IVD/2020/000338 Immunoshop India D-Dimer STAT (eCLIA)(Lifotronic)-Immunoassay CDSCO Class C

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932 IMP/IVD/2020/000349 Immunoshop India Wash Concentrate(MAGLUMI)-MAGLUMI Wash CDSCO Class A

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