CDRHNew - News and Updates | FDA

CDRHNew - News and Updates | FDA

CDRH New May 11, 2020 The Center for Devices and Radiological Health (CDRH) posted these new items on FDA.gov on May 8-9, 2020. To view listings for other dates, see CDRH New - News and Updates.

New Emergency Use Authorizations Rutgers Clinical Laboratory at RUCDR Infinite Biologics - Rutgers University Zymo Research Corporation Patient Isolation Transport Unit (PITU) Device Sofia 2 SARS Antigen FIA (Quidel Corporation) Gnomegen COVID-19-RT-qPCR Detection Kit Biocollections Worldwide SARS-Co-V-2 Assay Updated Emergency Use Authorizations Ventilators - Appendix B qSARS-CoV-2 IgG/IgM Rapid Test - IFU FAQs on Testing for SARS-CoV-2 (Updated) Consumer Information on: Tack Endovascular System® (4F, 1.5-4.5mm) - P190027