Page: FDA Authorization Information – PF273946

FDA Authorization Information

 

ALR195000:
• 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.