Important Safety Information
The BinaxNOW™ COVID-19 Antigen Self Test is a lateral flow immunoassay intended for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2 from individuals with or without symptoms or other epidemiological reasons to suspect COVID-19 infection when tested twice over three days with at least 24 hours (and no more than 48 hours) between tests. This test is authorized for non-prescription home use with self-collected direct anterior nasal (nares) swab samples from individuals aged 15 years or older or adult collected anterior nasal swab samples from individuals aged two years or older.
The BinaxNOW COVID-19 Ag Card has not been FDA cleared or approved. It has been authorized by the FDA under an emergency use authorization. It 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 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.