EUA Ihealth RapidTestAg ifuHT - 0 - 0
EUA Ihealth RapidTestAg ifuHT - 0 - 0
EUA Ihealth RapidTestAg ifuHT - 0 - 0
iHealth
Test Card. Screw back the small white cap.
Please follow proper steps based on the specific set you sample collection procedure for the other nostril. Be
sure to brush BOTH nostrils with the SAME SWAB. If the Control (C) line and the Test (T) line are visible,
received.
the test is positive.
Test Set 1: Open the package, take out the COVID-19 Below are photos of actual positive tests. Any
Test Card in Pouch, the Tube pre-filled with the
faint visible pink-to-purple test (T) line with the
COVID-19 extraction solution and the Swab. When you are ready
to proceed with the test, open the foil pouch of the
Slowly
Brush
Slowly
Brush
control line (C) should be read as positive.
COVID-19
For in vitro diagnostic use.
Determining a negative result requires multiple tests.
You may need to purchase additional tests to perform serial (repeat) testing.
This test is more likely to give you a false negative result when you have
This test can be performed with or without the supervision of a telehealth proctor, to access the
This test does NOT determine if you had COVID-19 in the past or if you have immunity.
As an aid in the diagnosis On anyone under 2 years of age In the USA, this product has not been FDA cleared or approved, but has been authorized
of COVID-19 by FDA under an EUA. This product has been authorized only for the detection of
If you are prone to nose bleeds proteins from SARS-CoV-2, not for any other viruses or pathogens.
If you are concerned that The emergency use of this product is only authorized for the duration of the declaration
you have been exposed If you have had a facial or head that circumstances exist justifying the authorization of emergency use of in vitro
to COVID-19 injury/surgery in the last 6 months diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the
Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration
Components is terminated or authorization is revoked sooner.
For more information on expiration dating for COVID-19 antigen tests, please refer to:
http://www.fda.gov/covid-tests
Use within 1 hour after opening the foil pouch of COVID-19 Test Card.
COVID-19 Test Card Swab Avoid contact of the extraction solution with your skin, eyes, nose or mouth.
Manufactured for iHealth Labs, Inc.
FDA
150C Charcot Ave, San Jose, CA 95131, USA
www.ihealthlabs.com 1-855-816-7705
Pre Filled Tube Empty Tube & Sealed Solution
Contents
1 × COVID-19 Test Card; 1 × Swab; 1 × Pre Filled Tube
Model: ICO-3000
For Emergency Use If you want to use the telehealth testing, please ICO-3001
Authorization(EUA) only do not open the kit package until instructed to do so. ICO-3002
iHealth Manufacturing Inc.
8 56362 00000 0
15715 Arrow Hwy, Irwindale, CA 91706
Scan the QR code to download the “iHealth COVID-19 Antigen
Rapid Test” App on smartphone.
Follow the instructional video in “iHealth COVID-19 Antigen Rapid Test” App to
quickly start the test. Materials required but are not provided in the kit:
For a full list of compatible smartphone visit: ihealthlabs.com/pages/support-ICO3000 Smartphone (iOS12.0+, Android 6.0+) Timer
COVID-19
iHealthLabs.com/air
proctor, to access the telehealth proctor services, please visit:
This test can be performed with or without the supervision of a telehealth
Antigen Rapid Test” App on smartphone.
Scan the QR code to download the “iHealth COVID-19
FDA
For Emergency Use If you want to use the telehealth testing, please
Authorization(EUA) only do not open the kit package until instructed to do so.
Components
This test does NOT determine if you had COVID-19 in the past or if you
Instrucciones de uso en español
have immunity.
ubicadas dentro de la App.
In the USA, this product has not been FDA cleared or approved, but has been
The iHealth COVID-19 Antigen Rapid Test is intended for the qualitative authorized by FDA under an EUA. This product has been authorized only for the
detection of SARS-CoV-2 nucleocapsid protein antigen in anterior nasal detection of proteins from SARS-CoV-2, not for any other viruses or pathogens.
(nares) swab samples. The emergency use of this product is only authorized for the duration of the
For in vitro diagnostic use. declaration that circumstances exist justifying the authorization of emergency use
of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section
Determining a negative result requires multiple tests.
564(b)(1) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1),
You may need to purchase additional tests to perform serial (repeat)
unless the declaration is terminated or authorization is revoked sooner.
testing. For more information on expiration dating for COVID-19 antigen tests, please
This test is more likely to give you a false negative result when you refer to: http://www.fda.gov/covid-tests
have COVID-19 than a lab-based molecular test.
DO USE DO NOT USE Contents
As an aid in the diagnosis On anyone under 2 years of age 2 × COVID-19 Test Cards; 2 × Swabs; 2 × Pre Filled Tubes
of COVID-19
If you are prone to nose bleeds 20856362005894
If you are concerned that
you have been exposed If you have had a facial or head
211CO21105
to COVID-19 injury/surgery in the last 6 months 2022-05-04
Manufactured for iHealth Labs, Inc. Model: ICO-3000 iHealth Manufacturing Inc.
150C Charcot Ave, San Jose, CA 95131, USA ICO-3001 15715 Arrow Hwy, Irwindale, CA 91706
www.ihealthlabs.com 1-855-816-7705
ICO-3002
Use within 1 hour after opening the foil pouch of COVID-19 Test Card.
Avoid contact of the extraction solution with your skin, eyes, nose or mouth.
Scan the QR code to download the “iHealth COVID-19 Antigen
Rapid Test” App on smartphone.
Follow the instructional video in “iHealth COVID-19 Antigen Rapid Test”
App to quickly start the test.
For a full list of compatible smartphone visit: ihealthlabs.com/pages/support-ICO3000
Materials required but are not provided in the kit: Smartphone (iOS12.0+, Android 6.0+) Timer
COVID-19
please visit: iHealthLabs.com/air
telehealth proctor, to access the telehealth proctor services,
This test can be performed with or without the supervision of a
COVID-19 Antigen Rapid Test” App on smartphone.
Scan the QR code to download the “iHealth
FDA
For Emergency Use If you want to use the telehealth testing, please
Authorization(EUA) only do not open the kit package until instructed to do so.
Components
FDA COVID-19 Test Card Swab Pre Filled Tube Empty Tube & Sealed Solution
For Emergency Use
Authorization(EUA) only
Instrucciones de uso en español This test does NOT determine if you had COVID-19 in the past or if you
ubicadas dentro de la App. have immunity.
In the USA, this product has not been FDA cleared or approved, but has been
The iHealth COVID-19 Antigen Rapid Test is intended for the qualitative authorized by FDA under an EUA. This product has been authorized only for the
detection of SARS-CoV-2 nucleocapsid protein antigen in anterior nasal detection of proteins from SARS-CoV-2, not for any other viruses or pathogens.
(nares) swab samples. The emergency use of this product is only authorized for the duration of the
For in vitro diagnostic use. declaration that circumstances exist justifying the authorization of emergency use
Determining a negative result requires multiple tests. of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section
You may need to purchase additional tests to perform serial (repeat) 564(b)(1) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1),
unless the declaration is terminated or authorization is revoked sooner.
testing.
For more information on expiration dating for COVID-19 antigen tests, please
This test is more likely to give you a false negative result when you
refer to: http://www.fda.gov/covid-tests
have COVID-19 than a lab-based molecular test.
Manufactured for iHealth Labs, Inc. Model: ICO-3000 iHealth Manufacturing Inc.
150C Charcot Ave, San Jose, CA 95131 USA 15715 Arrow Hwy, Irwindale, CA 91706
ICO-3001
www.ihealthlabs.com 1-855-816-7705 ICO-3002
Use within 1 hour after opening the foil pouch of COVID-19 Test Card.
Avoid contact of the extraction solution with your skin, eyes, nose or mouth.
Scan the QR code to download the “iHealth COVID-19 Antigen
Rapid Test” App on smartphone.
Follow the instructional video in “iHealth COVID-19 Antigen Rapid Test”
App to quickly start the test.
For a full list of compatible smartphone visit: ihealthlabs.com/pages/support-ICO3000
Materials required but are not provided in the kit: Smartphone (iOS12.0+, Android 6.0+) Timer
COVID-19
please visit: iHealthLabs.com/air
telehealth proctor, to access the telehealth proctor services,
This test can be performed with or without the supervision of a
COVID-19 Antigen Rapid Test” App on smartphone.
Scan the QR code to download the “iHealth
FDA
For Emergency Use If you want to use the telehealth testing, please
Authorization(EUA) only do not open the kit package until instructed to do so.
Components
COVID-19 Test Card Swab Pre Filled Tube Empty Tube & Sealed Solution
Instrucciones de uso en español This test does NOT determine if you had COVID-19 in the past or if you
ubicadas dentro de la App. have immunity.
In the USA, this product has not been FDA cleared or approved, but has been
The iHealth COVID-19 Antigen Rapid Test is intended for the qualitative authorized by FDA under an EUA. This product has been authorized only for the
detection of SARS-CoV-2 nucleocapsid protein antigen in anterior nasal detection of proteins from SARS-CoV-2, not for any other viruses or pathogens.
(nares) swab samples. The emergency use of this product is only authorized for the duration of the
For in vitro diagnostic use. declaration that circumstances exist justifying the authorization of emergency use
Determining a negative result requires multiple tests. of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section
564(b)(1) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1),
You may need to purchase additional tests to perform serial (repeat)
unless the declaration is terminated or authorization is revoked sooner.
testing.
For more information on expiration dating for COVID-19 antigen tests, please
This test is more likely to give you a false negative result when you refer to: http://www.fda.gov/covid-tests
have COVID-19 than a lab-based molecular test.
Manufactured for iHealth Labs, Inc. Model: ICO-3000 iHealth Manufacturing Inc.
150C Charcot Ave, San Jose, CA 95131 USA 15715 Arrow Hwy, Irwindale, CA 91706
ICO-3001
www.ihealthlabs.com 1-855-816-7705 ICO-3002
Use within 1 hour after opening the foil pouch of COVID-19 Test Card.
Avoid contact of the extraction solution with your skin, eyes, nose or mouth.
Scan the QR code to download the “iHealth COVID-19 Antigen
Rapid Test” App on smartphone.
Follow the instructional video in “iHealth COVID-19 Antigen Rapid Test”
App to quickly start the test.
For a full list of compatible smartphone visit: ihealthlabs.com/pages/support-ICO3000
Materials required but are not provided in the kit: Smartphone (iOS12.0+, Android 6.0+) Timer
COVID-19
please visit: iHealthLabs.com/air
telehealth proctor, to access the telehealth proctor services,
This test can be performed with or without the supervision of a
COVID-19 Antigen Rapid Test” App on smartphone.
Scan the QR code to download the “iHealth
FDA
For Emergency Use If you want to use the telehealth testing, please
Authorization(EUA) only do not open the kit package until instructed to do so.
Components
COVID-19 Test Card Swab Pre Filled Tube Empty Tube & Sealed Solution
Instrucciones de uso en español This test does NOT determine if you had COVID-19 in the past or if you
ubicadas dentro de la App. have immunity.
In the USA, this product has not been FDA cleared or approved, but has been
The iHealth COVID-19 Antigen Rapid Test is intended for the qualitative authorized by FDA under an EUA. This product has been authorized only for the
detection of SARS-CoV-2 nucleocapsid protein antigen in anterior nasal detection of proteins from SARS-CoV-2, not for any other viruses or pathogens.
(nares) swab samples. The emergency use of this product is only authorized for the duration of the
For in vitro diagnostic use. declaration that circumstances exist justifying the authorization of emergency use
Determining a negative result requires multiple tests. of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section
564(b)(1) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1),
You may need to purchase additional tests to perform serial (repeat)
unless the declaration is terminated or authorization is revoked sooner.
testing.
For more information on expiration dating for COVID-19 antigen tests, please
This test is more likely to give you a false negative result when you refer to: http://www.fda.gov/covid-tests
have COVID-19 than a lab-based molecular test.
Manufactured for iHealth Labs, Inc. Model: ICO-3000 iHealth Manufacturing Inc.
150C Charcot Ave, San Jose, CA 95131 USA 15715 Arrow Hwy, Irwindale, CA 91706
ICO-3001
www.ihealthlabs.com 1-855-816-7705 ICO-3002
Use within 1 hour after opening the foil pouch of COVID-19 Test Card.
Avoid contact of the extraction solution with your skin, eyes, nose or mouth.
do not open the kit package until instructed to do so. Authorization(EUA) only
If you want to use the telehealth testing, please For Emergency Use
FDA
Instrucciones de uso en español Use within 1 hour after opening the foil pouch of COVID-19 Test Card.
ubicadas dentro de la App. Avoid contact of the extraction solution with your skin, eyes, nose or mouth.
The iHealth COVID-19 Antigen Rapid Test is intended for the qualitative detection of
This test does NOT determine if you had COVID-19 in the past or if you have immunity.
SARS-CoV-2 nucleocapsid protein antigen in anterior nasal (nares) swab samples.
Components
In the USA, this product has not been FDA cleared or approved, but has been authorized
For in vitro diagnostic use.
by FDA under an EUA. This product has been authorized only for the detection of
Determining a negative result requires multiple tests.
proteins from SARS-CoV-2, not for any other viruses or pathogens.
You may need to purchase additional tests to perform serial (repeat) testing.
The emergency use of this product is only authorized for the duration of the declaration
This test is more likely to give you a false negative result when you have COVID-19
that circumstances exist justifying the authorization of emergency use of in vitro
than a lab-based molecular test.
diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the
DO USE DO NOT USE Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is
terminated or authorization is revoked sooner.
As an aid in the diagnosis On anyone under 2 years of age
For more information on expiration dating for COVID-19 antigen tests, please refer to:
Scan the QR code to download the “iHealth COVID-19 Antigen of COVID-19
If you are prone to nose bleeds http://www.fda.gov/covid-tests
Rapid Test” App on smartphone. If you are concerned that
This test can be performed with or without the supervision of a COVID-19 Test Card Swab you have been exposed If you have had a facial or head Contents
Pre Filled Tube Empty Tube & Sealed Solution
telehealth proctor, to access the telehealth proctor services, please to COVID-19 injury/surgery in the last 6 months 40 × COVID-19 Test Cards; 40 × Swabs; 40 × Pre Filled Tubes
visit: iHealthLabs.com/air Manufactured for iHealth Labs, Inc.
20856362005894
150C Charcot Ave, San Jose, CA 95131, USA
www.ihealthlabs.com 1-855-816-7705 211CO21105
Model: ICO-3000 2022-05-04
ICO-3001
iHealth Manufacturing Inc.
ICO-3002 15715 Arrow Hwy, Irwindale, CA 91706
Scan the QR code to download the “iHealth COVID-19 Antigen
Instrucciones de uso en español ubicadas Rapid Test” App on smartphone.
dentro de la App. Follow the instructional video in “iHealth COVID-19 Antigen Rapid Test”
The iHealth COVID-19 Antigen Rapid Test is intended for the qualitative detection of App to quickly start the test.
For a full list of compatible smartphone visit: ihealthlabs.com/pages/support-ICO3000
SARS-CoV-2 nucleocapsid protein antigen in anterior nasal (nares) swab samples.
Materials required but are not provided in the kit: Smartphone (iOS12.0+, Android 6.0+) Timer
COVID-19
For in vitro diagnostic use.
Determining a negative result requires multiple tests.
You may need to purchase additional tests to perform serial (repeat) testing.
This test is more likely to give you a false negative result when you have
This test can be performed with or without the supervision of a telehealth proctor, to access the
This test does NOT determine if you had COVID-19 in the past or if you have immunity.
As an aid in the diagnosis On anyone under 2 years of age In the USA, this product has not been FDA cleared or approved, but has been authorized
of COVID-19 by FDA under an EUA. This product has been authorized only for the detection of
If you are prone to nose bleeds proteins from SARS-CoV-2, not for any other viruses or pathogens.
If you are concerned that The emergency use of this product is only authorized for the duration of the declaration
you have been exposed If you have had a facial or head that circumstances exist justifying the authorization of emergency use of in vitro
to COVID-19 injury/surgery in the last 6 months diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the
Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration
Components is terminated or authorization is revoked sooner.
For more information on expiration dating for COVID-19 antigen tests, please refer to:
http://www.fda.gov/covid-tests
Use within 1 hour after opening the foil pouch of COVID-19 Test Card.
COVID-19 Test Card Swab Avoid contact of the extraction solution with your skin, eyes, nose or mouth.
Manufactured for iHealth Labs, Inc.
FDA
150C Charcot Ave, San Jose, CA 95131, USA
www.ihealthlabs.com 1-855-816-7705
Pre Filled Tube Empty Tube & Sealed Solution
Contents
1 × COVID-19 Test Card; 1 × Swab; 1 × Pre Filled Tube
Model: ICO-3000
For Emergency Use If you want to use the telehealth testing, please ICO-3001
Authorization(EUA) only do not open the kit package until instructed to do so. ICO-3002 8 56362 00000 0
Made in China
Scan the QR code to download the “iHealth COVID-19 Antigen
Rapid Test” App on smartphone.
Follow the instructional video in “iHealth COVID-19 Antigen Rapid Test” App to
quickly start the test. Materials required but are not provided in the kit:
For a full list of compatible smartphone visit: ihealthlabs.com/pages/support-ICO3000 Smartphone (iOS12.0+, Android 6.0+) Timer
COVID-19
iHealthLabs.com/air
proctor, to access the telehealth proctor services, please visit:
This test can be performed with or without the supervision of a telehealth
Antigen Rapid Test” App on smartphone.
Scan the QR code to download the “iHealth COVID-19
FDA
For Emergency Use If you want to use the telehealth testing, please
Authorization(EUA) only do not open the kit package until instructed to do so.
Components
This test does NOT determine if you had COVID-19 in the past or if you
Instrucciones de uso en español
have immunity.
ubicadas dentro de la App.
In the USA, this product has not been FDA cleared or approved, but has been
The iHealth COVID-19 Antigen Rapid Test is intended for the qualitative authorized by FDA under an EUA. This product has been authorized only for the
detection of SARS-CoV-2 nucleocapsid protein antigen in anterior nasal detection of proteins from SARS-CoV-2, not for any other viruses or pathogens.
(nares) swab samples. The emergency use of this product is only authorized for the duration of the
For in vitro diagnostic use. declaration that circumstances exist justifying the authorization of emergency use
of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section
Determining a negative result requires multiple tests.
564(b)(1) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1),
You may need to purchase additional tests to perform serial (repeat)
unless the declaration is terminated or authorization is revoked sooner.
testing. For more information on expiration dating for COVID-19 antigen tests, please
This test is more likely to give you a false negative result when you refer to: http://www.fda.gov/covid-tests
have COVID-19 than a lab-based molecular test.
DO USE DO NOT USE Contents
As an aid in the diagnosis On anyone under 2 years of age 2 × COVID-19 Test Cards; 2 × Swabs; 2 × Pre Filled Tubes
of COVID-19
If you are prone to nose bleeds 20856362005894
If you are concerned that
you have been exposed If you have had a facial or head
211CO21105
to COVID-19 injury/surgery in the last 6 months 2022-05-04
Manufactured for iHealth Labs, Inc. Model: ICO-3000
150C Charcot Ave, San Jose, CA 95131, USA Made in China
ICO-3001
www.ihealthlabs.com 1-855-816-7705
ICO-3002
Use within 1 hour after opening the foil pouch of COVID-19 Test Card.
Avoid contact of the extraction solution with your skin, eyes, nose or mouth.
Scan the QR code to download the “iHealth COVID-19 Antigen
Rapid Test” App on smartphone.
Follow the instructional video in “iHealth COVID-19 Antigen Rapid Test”
App to quickly start the test.
For a full list of compatible smartphone visit: ihealthlabs.com/pages/support-ICO3000
Materials required but are not provided in the kit: Smartphone (iOS12.0+, Android 6.0+) Timer
COVID-19
please visit: iHealthLabs.com/air
telehealth proctor, to access the telehealth proctor services,
This test can be performed with or without the supervision of a
COVID-19 Antigen Rapid Test” App on smartphone.
Scan the QR code to download the “iHealth
FDA
For Emergency Use If you want to use the telehealth testing, please
Authorization(EUA) only do not open the kit package until instructed to do so.
Components
FDA COVID-19 Test Card Swab Pre Filled Tube Empty Tube & Sealed Solution
For Emergency Use
Authorization(EUA) only
Instrucciones de uso en español This test does NOT determine if you had COVID-19 in the past or if you
ubicadas dentro de la App. have immunity.
In the USA, this product has not been FDA cleared or approved, but has been
The iHealth COVID-19 Antigen Rapid Test is intended for the qualitative authorized by FDA under an EUA. This product has been authorized only for the
detection of SARS-CoV-2 nucleocapsid protein antigen in anterior nasal detection of proteins from SARS-CoV-2, not for any other viruses or pathogens.
(nares) swab samples. The emergency use of this product is only authorized for the duration of the
For in vitro diagnostic use. declaration that circumstances exist justifying the authorization of emergency use
Determining a negative result requires multiple tests. of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section
You may need to purchase additional tests to perform serial (repeat) 564(b)(1) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1),
unless the declaration is terminated or authorization is revoked sooner.
testing.
For more information on expiration dating for COVID-19 antigen tests, please
This test is more likely to give you a false negative result when you
refer to: http://www.fda.gov/covid-tests
have COVID-19 than a lab-based molecular test.
Use within 1 hour after opening the foil pouch of COVID-19 Test Card.
Avoid contact of the extraction solution with your skin, eyes, nose or mouth.
Scan the QR code to download the “iHealth COVID-19 Antigen
Rapid Test” App on smartphone.
Follow the instructional video in “iHealth COVID-19 Antigen Rapid Test”
App to quickly start the test.
For a full list of compatible smartphone visit: ihealthlabs.com/pages/support-ICO3000
Materials required but are not provided in the kit: Smartphone (iOS12.0+, Android 6.0+) Timer
COVID-19
please visit: iHealthLabs.com/air
telehealth proctor, to access the telehealth proctor services,
This test can be performed with or without the supervision of a
COVID-19 Antigen Rapid Test” App on smartphone.
Scan the QR code to download the “iHealth
FDA
For Emergency Use If you want to use the telehealth testing, please
Authorization(EUA) only do not open the kit package until instructed to do so.
Components
COVID-19 Test Card Swab Pre Filled Tube Empty Tube & Sealed Solution
Instrucciones de uso en español This test does NOT determine if you had COVID-19 in the past or if you
ubicadas dentro de la App. have immunity.
In the USA, this product has not been FDA cleared or approved, but has been
The iHealth COVID-19 Antigen Rapid Test is intended for the qualitative authorized by FDA under an EUA. This product has been authorized only for the
detection of SARS-CoV-2 nucleocapsid protein antigen in anterior nasal detection of proteins from SARS-CoV-2, not for any other viruses or pathogens.
(nares) swab samples. The emergency use of this product is only authorized for the duration of the
For in vitro diagnostic use. declaration that circumstances exist justifying the authorization of emergency use
Determining a negative result requires multiple tests. of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section
564(b)(1) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1),
You may need to purchase additional tests to perform serial (repeat)
unless the declaration is terminated or authorization is revoked sooner.
testing.
For more information on expiration dating for COVID-19 antigen tests, please
This test is more likely to give you a false negative result when you refer to: http://www.fda.gov/covid-tests
have COVID-19 than a lab-based molecular test.
Use within 1 hour after opening the foil pouch of COVID-19 Test Card.
Avoid contact of the extraction solution with your skin, eyes, nose or mouth.
Scan the QR code to download the “iHealth COVID-19 Antigen
Rapid Test” App on smartphone.
Follow the instructional video in “iHealth COVID-19 Antigen Rapid Test”
App to quickly start the test.
For a full list of compatible smartphone visit: ihealthlabs.com/pages/support-ICO3000
Materials required but are not provided in the kit: Smartphone (iOS12.0+, Android 6.0+) Timer
COVID-19
please visit: iHealthLabs.com/air
telehealth proctor, to access the telehealth proctor services,
This test can be performed with or without the supervision of a
COVID-19 Antigen Rapid Test” App on smartphone.
Scan the QR code to download the “iHealth
FDA
For Emergency Use If you want to use the telehealth testing, please
Authorization(EUA) only do not open the kit package until instructed to do so.
Components
COVID-19 Test Card Swab Pre Filled Tube Empty Tube & Sealed Solution
Instrucciones de uso en español This test does NOT determine if you had COVID-19 in the past or if you
ubicadas dentro de la App. have immunity.
In the USA, this product has not been FDA cleared or approved, but has been
The iHealth COVID-19 Antigen Rapid Test is intended for the qualitative authorized by FDA under an EUA. This product has been authorized only for the
detection of SARS-CoV-2 nucleocapsid protein antigen in anterior nasal detection of proteins from SARS-CoV-2, not for any other viruses or pathogens.
(nares) swab samples. The emergency use of this product is only authorized for the duration of the
For in vitro diagnostic use. declaration that circumstances exist justifying the authorization of emergency use
Determining a negative result requires multiple tests. of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section
564(b)(1) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1),
You may need to purchase additional tests to perform serial (repeat)
unless the declaration is terminated or authorization is revoked sooner.
testing.
For more information on expiration dating for COVID-19 antigen tests, please
This test is more likely to give you a false negative result when you refer to: http://www.fda.gov/covid-tests
have COVID-19 than a lab-based molecular test.
Use within 1 hour after opening the foil pouch of COVID-19 Test Card.
Avoid contact of the extraction solution with your skin, eyes, nose or mouth.
do not open the kit package until instructed to do so. Authorization(EUA) only
If you want to use the telehealth testing, please For Emergency Use
FDA
Instrucciones de uso en español Use within 1 hour after opening the foil pouch of COVID-19 Test Card.
ubicadas dentro de la App. Avoid contact of the extraction solution with your skin, eyes, nose or mouth.
The iHealth COVID-19 Antigen Rapid Test is intended for the qualitative detection of
This test does NOT determine if you had COVID-19 in the past or if you have immunity.
SARS-CoV-2 nucleocapsid protein antigen in anterior nasal (nares) swab samples.
Components
In the USA, this product has not been FDA cleared or approved, but has been authorized
For in vitro diagnostic use.
by FDA under an EUA. This product has been authorized only for the detection of
Determining a negative result requires multiple tests.
proteins from SARS-CoV-2, not for any other viruses or pathogens.
You may need to purchase additional tests to perform serial (repeat) testing.
The emergency use of this product is only authorized for the duration of the declaration
This test is more likely to give you a false negative result when you have COVID-19
that circumstances exist justifying the authorization of emergency use of in vitro
than a lab-based molecular test.
diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the
DO USE DO NOT USE Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is
terminated or authorization is revoked sooner.
As an aid in the diagnosis On anyone under 2 years of age
For more information on expiration dating for COVID-19 antigen tests, please refer to:
Scan the QR code to download the “iHealth COVID-19 Antigen of COVID-19
If you are prone to nose bleeds http://www.fda.gov/covid-tests
Rapid Test” App on smartphone. If you are concerned that
This test can be performed with or without the supervision of a COVID-19 Test Card Swab you have been exposed If you have had a facial or head Contents
Pre Filled Tube Empty Tube & Sealed Solution
telehealth proctor, to access the telehealth proctor services, please to COVID-19 injury/surgery in the last 6 months 40 × COVID-19 Test Cards; 40 × Swabs; 40 × Pre Filled Tubes
visit: iHealthLabs.com/air Manufactured for iHealth Labs, Inc.
20856362005894
150C Charcot Ave, San Jose, CA 95131, USA
www.ihealthlabs.com 1-855-816-7705 211CO21105
Model: ICO-3000 2022-05-04
ICO-3001
Made in China
ICO-3002