Page: FDA Authorization Information – Veritor SARS-CoV-2 System PF263979

BDD256088:
• Minimum shelf life guarantee of 30 days
• Non-returnable
• This product has not been FDA cleared or approved, but has been authorized by FDA under an EUA for use by authorized laboratories;
• This product has been authorized only for the detection of proteins from SARS-CoV-2, influenza A and influenza B, not for any other viruses or pathogens; and,
• 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

BDD256082:
• Minimum shelf life guarantee of 30 days
• Non-returnable
• This product has not been FDA cleared or approved; but has been authorized by FDA under an EUA for use by authorized laboratories;
• This product has been authorized only for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens; and,
• 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

See the Documents/SDS area for specific FDA authorization for use information.