![]() † Before testing patients, federal regulations require testing sites to have a CLIA certificate issued by CMS. **Refer to the product package insert for full instructions and clinical data. ![]() § 360bbb-3(b)(1), unless the declaration is terminated or authorization is revoked sooner. They have been authorized only for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens, and are 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. They have been authorized by the FDA under an emergency use authorization. * The BinaxNOW COVID-19 Ag Card and BinaxNOW COVID-19 Ag 2 Card have not been FDA cleared or approved. ![]() Google Play and the Google Play Logo are trademarks of Google LLC.Īpp Store and the Apple Logo are trademarks of Apple Inc.
0 Comments
Leave a Reply. |