Authorized Reseller of Lucira by Pfizer
NDC Code: 00069970131
Product shelf life minimum: June 2025
- THE FIRST 2-in-1 SINGLE-USE SCREENING HOME TEST Offers professional testing from the comfort of your home
- AT-HOME TESTING: Quickly test for SARS-CoV-2, influenza A, and influenza B in the comfort of your home-and get results in 30 minutes
- HSA/FSA ELIGIBLE: Test is HSA/FSA eligible and may be reimbursable by insurance. Contact your health insurance company to learn more
- FOR AGES 2+: Shallow, anterior nasal swab collection for individuals 14 years or older if self-collected or individuals 2 to 13 years if collected by an adult
- EMERGENCY USE AUTHORIZATION (EUA): Please see full EUA language in the image carousel (second image) or below in the Legal Disclaimer section of this page
-
PLEASE SEE all authorized labeling for this test at the LUCIRA by Pfizer website http://lucirabypfizer.com/labeling.
Directions
INDICATION FOR USE: The Lucira® by Pfizer at-Home screening 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 SARS-CoV-2.
Legal Disclaimer
EMERGENCY USE AUTHORIZATION (EUA): LUCIRA by Pfizer at-Home screening 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 SARS-CoV-2 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.
