These home tests have not been FDA cleared or approved. These home tests have been authorized by FDA under Emergency Use Authorization (EUA). These home tests have been authorized only for the testing of nasal swabs for detection of nucleic acid from SARS-CoV-2 alone, or from SARS-CoV-2, influenza A, and influenza B; not for any other viruses or pathogens. These home tests are only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of IVDs for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated or revoked sooner.