Read the Emergency Use Authorization for LUCIRA® by Pfizer COVID-19 & Flu Test
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authorized labelling - banner

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Authorized Labeling

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A shot of the LUCIRA® by Pfizer product box, which is light and dark blue with the white device on the front of the box. A shot of the LUCIRA® by Pfizer product box, which is light and dark blue with the white device on the front of the box.

Emergency Use Authorization

The LUCIRA® by Pfizer COVID-19 & Flu Test has not been FDA cleared or approved, but has been authorized for emergency use by FDA under an EUA for use by authorized laboratories. This product 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 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.

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LUCIRA® by Pfizer COVID-19 & Flu Test Labeling
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