Lucira by Pfizer COVID-19 & Flu Home Test, 1 CT

Not applicable

1. Using sterile technique, tilt the patient’s head back and insert swab into the nostril until resistance is felt.2. Roll the swab five times around, touching the nostril walls. Repeat on the other nostril.3. Insert the swab into the sample vial until it touches the bottom. Stir it around the bottom of the sample vial 15 times. Discard the swab after stirring.4. Snap the lid of the sample vial closed and press the vial down into the tester until it clicks. Test is running when ‘ready’ light is blinking.

Emergency Use AuthorizationThe 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.