Product Detail

• 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 COVID-19 than a lab-based molecular test. • This product does not determine if you had COVID-19 or influenza A or influenza B in the past or if you have immunity. • Persons with risk factors for severe disease from respiratory pathogens should consult and follow-up with a healthcare provider. • For Over the Counter (OTC) use. • For use with self-collected anterior nasal swab specimen. • For ages 2 and up. For ages 2-14, an adult must collect and conduct the test. • Keep testing kit and kit components out of the reach of children. • This test is only authorized for individuals with signs and symptoms of respiratory infection consistent with COVID-19 within the first five (5) days of symptom onset when tested at least twice over three days with at least 48 hours between tests. In the USA, this product has not been FDA cleared or approved; but has been authorized by FDA under an emergency use authorization. This product has been authorized only for the detection of proteins from SARS-CoV-2, influenza A and influenza B, not for any other viruses or pathogens. The emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use 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), unless the declaration is terminated or authorization is revoked sooner.

Brand Information

Product Detail

• 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 COVID-19 than a lab-based molecular test. • This product does not determine if you had COVID-19 or influenza A or influenza B in the past or if you have immunity. • Persons with risk factors for severe disease from respiratory pathogens should consult and follow-up with a healthcare provider. • For Over the Counter (OTC) use. • For use with self-collected anterior nasal swab specimen. • For ages 2 and up. For ages 2-14, an adult must collect and conduct the test. • Keep testing kit and kit components out of the reach of children. • This test is only authorized for individuals with signs and symptoms of respiratory infection consistent with COVID-19 within the first five (5) days of symptom onset when tested at least twice over three days with at least 48 hours between tests. In the USA, this product has not been FDA cleared or approved; but has been authorized by FDA under an emergency use authorization. This product has been authorized only for the detection of proteins from SARS-CoV-2, influenza A and influenza B, not for any other viruses or pathogens. The emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use 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), unless the declaration is terminated or authorization is revoked sooner.

Preparation & Usage

Features

For emergency use authorization (EUA) only

For in vitro diagnostic use