§ 360bbb-3(b)(1), unless the declaration is terminated or authorization is revoked sooner. *This product has not been FDA cleared or approved but has been authorized by FDA under an EUA 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. PRISM is a research laboratory at Indiana University - Purdue University Indianapolis that focuses on risk for substance use and other health behaviors.
0 Comments
Leave a Reply. |
AuthorWrite something about yourself. No need to be fancy, just an overview. ArchivesCategories |