CDRHNew - News and Updates | FDA

CDRHNew - News and Updates | FDA

CDRH New June 30, 2020 The Center for Devices and Radiological Health (CDRH) posted these new items on FDA.gov on June 29, 2020. To view listings for other dates, see CDRH New - News and Updates.

New Emergency Use Authorization LifeHope 2019-nCoV Real-Time RT-PCR Diagnostic Panel (LifeHope Labs) Access SARS-CoV-2 IgG (Beckman Coulter, Inc.) Updated Emergency Use Authorizations Appendix A: Non-NIOSH-Approved Disposable Filtering Facepiece Respirators Manufactured in China Appendix B: Authorized Ventilators IntelliPlex SARS-CoV-2 Detection Kit (PlexBio Co., Ltd.) (IFU, Patients) Consumer Information on: Inspire® Upper Airway Stimulation - P130008/S039 EUA Authorized Serology Test Performance (Updated) Presentation and Transcript added to June 24 Virtual Town Hall Series - Immediately in Effect Guidance on Coronavirus (COVID-19) Diagnostic Tests FAQs on Testing for SARS-CoV-2 (Updated)