Page: FDA Authorization Information – PF289982 – SCoV-2 Ag Detect Rapid Self-Test

CDYCAGS2:
• This test has not been FDA cleared or approved, but has been authorized by FDA under an EUA for use by authorized laboratories;
• Non-returnable
• This product 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 test has been authorized only for the detection of proteins from SARSCoV-2, influenza A and influenza B, not for any other viruses or pathogens; and
• The emergency use of this test 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