Read the Emergency Use Authorization for LUCIRA® by Pfizer COVID-19 & Flu Test
Authorized labeling
Picture is for illustrative purposes only. Please see package insert instructions for proper handling and usage.
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.
LUCIRA® by Pfizer COVID-19 & Flu Test Labeling
*The LUCIRA® by Pfizer COVID-19 & Flu Test provides a level of accuracy comparable to highly sensitive lab-based polymerase chain reaction (PCR) tests. Negative results do not preclude SARS-CoV-2, influenza A, and/or influenza B infection and should not be used as the sole basis for patient management decisions.1
Reference: 1. LUCIRA® by Pfizer COVID-19 & Flu Test. Instructions for Use. Pfizer Inc; 2023.