CDRHNew - News and Updates | FDA

CDRHNew - News and Updates | FDA

CDRH New June 17, 2020 The Center for Devices and Radiological Health (CDRH) posted these new items on FDA.gov on June 16, 2020. To view listings for other dates, see CDRH New - News and Updates.

New Emergency Use Authorizations BioCode SARS-CoV-2 Assay (Applied BioCode, Inc.) SARS-CoV-2 RBD IgG test (Emory Medical Laboratories) KPMAS COVID-19 Test (Kaiser Permanente Mid-Atlantic States) Updated Emergency Use Authorizations Appendix A: Non-NIOSH-Approved Disposable Filtering Facepiece Respirators Manufactured in China Fulgent COVID-19 by RT-PCR Test (Fulgent Therapeutics, LLC) CDC 2019-nCoV Real-Time RT-PCR Diagnostic Panel (Centers for Disease Control and Prevention's (CDC)) Warrior Diagnostics SARS-CoV-2 Assay (Warrior Diagnostics, Inc.) Revoked Emergency Use Authorization DPP COVID-19 IgM/IgG System (Chembio Diagnostic System, Inc.) Class I Recall: Endologix Inc. Recalls Ovation iX Abdominal Stent Graft Systems Due to Risks of Polymer Leaks During Implantation FAQs on Testing for SARS-CoV-2 (Updated) FDA News Release: Coronavirus (COVID-19) Update: Facilitating Diagnostic Test Availability for Asymptomatic Testing and Sample Pooling FDA News Release: Coronavirus (COVID-19) Update: FDA Revokes Emergency Use Authorization for Chembio Antibody Test