Page: FDA Authorization Information – PF269691

FDA Authorization Information

 

BID0921110119:
• Minimum shelf life guarantee of 30 days
• Non-returnable
• This test has not been FDA cleared or approved; but has been authorized by FDA under an EUA for use by authorized laboratories;
• This test has been authorized only for the simultaneous qualitative detection and differentiation of nucleic acid from SARS-CoV-2, influenza A virus, and influenza B virus, and not for any other viruses or pathogens; and
• 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 authorization is terminated or revoked sooner