CDRHNew - News and Updates | FDA

CDRHNew - News and Updates | FDA

CDRH New July 27, 2020 The Center for Devices and Radiological Health (CDRH) posted these new items on FDA.gov on July 24, 2020. To view listings for other dates, see CDRH New - News and Updates.

New Emergency Use Authorizations Helix COVID-19 Test (Helix OpCo LLC (dba Helix)) Novel Coronavirus (SARS-CoV-2) Fast Nucleic Acid Detection Kit (PCR-Fluorescence Probing) (Jiangsu CoWin Biotech Co., Ltd.) Updated Emergency Use Authorizations Appendix A: Authorized Imported, Non-NIOSH Approved Respirators Manufactured in China RightSign COVID-19 IgG/IgM Rapid Test Cassette (Hangzhou Biotest Biotech Co., Ltd.) BD Veritor System for Rapid Detection of SARS-CoV-2 (Becton, Dickinson and Company (BD)) Aptima SARS-CoV-2 assay (Hologic, Inc. (BD)) COVID-19 RT-PCR Test (Laboratory Corporation of America (LabCorp)) FAQs on Testing for SARS-CoV-2 (Updated) MedSun Newsletter, July 2020 FDA News Release: Coronavirus (COVID-19) Update: FDA Authorizes First Diagnostic Test for Screening of People Without Known or Suspected COVID-19 Infection