CDRHNew - News and Updates | FDA

CDRHNew - News and Updates | FDA

CDRH New September 1, 2020 The Center for Devices and Radiological Health (CDRH) posted these new items on FDA.gov on August 31, 2020. To view listings for other dates, see CDRH New - News and Updates.

New Emergency Use Authorizations PCL SARS-CoV-2 Real-Time RT-PCR Assay (Patients Choice Laboratories, LLC) DxTerity SARS-CoV-2 RT PCR CE Test (DxTerity Diagnostics, Inc.) Updated Emergency Use Authorizations SARS-CoV-2 (N gene detection) Test (Exact Sciences Laboratories) (EUA Summary, IFU, Revision) Color Genomics SARS-CoV-2 RT-LAMP Diagnostic Assay (Color Genomics, Inc.) (EUA Summary, HCP, Patients, Revision) Novel Coronavirus (SARS-CoV-2) Fast Nucleic Acid Detection Kit (PCR-Fluorescence Probing) (Jiangsu CoWin Biotech Co., Ltd.) (IFU) SalivaDirect (Yale School of Public Health, Department of Epidemiology of Microbial Diseases) (Letter, HCP, Patients) Appendix A: Authorized Imported, Non-NIOSH Approved Respirators Manufactured in China Webinar Reminder - CDC/NIOSH's Surgical N95 Respirator Guidance - September 1, 2020 FAQs on Testing for SARS-CoV-2 (Updated)