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BinaxNOW™ COVID-19 Ag Card Home Test and NAVICA™ App

At-home COVID-19 antigen testing provides rapid results in the safety and convenience of your home

The 15-minute BinaxNOW™ COVID-19 Ag Card Home Test has received FDA Emergency Use Authorization for at-home testing in collaboration with eMed, a digital health solution. This first-of-its kind service for COVID-19 testing  prescribes and ships the test directly to your home. A trained telehealth professional then guides you through the at-home self-test via video call using the BinaxNOW COVID-19 Ag Card Home Test and Abbott’s complementary NAVICA™ mobile app to enable the testing process and display BinaxNOW COVID-19 test results. 

Prescription home use. Only available in the US.

References

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The BinaxNOW™ COVID-19 Ag Card Home Test has not been FDA cleared or approved. It has been authorized by the FDA under an emergency use authorization. The test has been authorized only for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens, and is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests 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.

   

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