LUCIRA® by Pfizer COVID-19 & Flu Home Test has not been FDA cleared or approved but has been authorized for emergency use by FDA under an Emergency Use Authorization (EUA). It has been authorized only for the detection and differentiation of nucleic acid from SARS-CoV-2, influenza A, and influenza B, not for any other viruses or pathogens. The authorization is 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 Act, 21 U.S.C.
§ 360bbb-3(b)(1), unless the declaration is terminated or authorization is revoked sooner.
The LUCIRA® by Pfizer COVID-19 & Flu Home Test is authorized for the simultaneous qualitative detection and differentiation of SARS-CoV-2, influenza A, and influenza B viral nucleic acid. This test is authorized for non-prescription home use with anterior nasal swab samples from individuals 14 years or older (self-collected) or individuals 2 years or older (collected by an adult) with signs and symptoms consistent with a respiratory tract infection including COVID-19.