CDRH New

June 15, 2020

The Center for Devices and Radiological Health (CDRH) posted these new items on FDA.gov on June 12, 2020. To view listings for other dates, see CDRH New - News and Updates.

New Emergency Use Authorizations
Diagnovital SARS-CoV-2 Real-Time PCR Kit (RTA Laboratories Biological Products Pharmaceutical and Machinery Industry)
Cormeum SARS-CoV-2 Assay (Cormeum Laboratory Services)
Updated Emergency Use Authorizations
qSARS-CoV-2 IgG/IgM Rapid Test (Cellex Inc.)
CDC 2019-nCoV Real-Time RT-PCR Diagnostic Panel (Centers for Disease Control and Prevention's (CDC))
BD SARS-CoV-2Reagents for BD MAX System (Becton, Dickinson & Company)
FAQs on Testing for SARS-CoV-2 (Updated)