CDRH New - May 6, 2020

CDRH New May 6, 2020 The Center for Devices and Radiological Health (CDRH) posted these new items on FDA.gov on May 5, 2020. To view listings for other dates, see CDRH New - News and Updates.

New Emergency Use Authorizations: Sansure Biotech Inc. Appendix A: UTMG Pathology Laboratory Letter of Authorization and EUA Summary Fast Track Diagnostics SARS-CoV-2 PhysiolGuard, ECG-QT Analysis System Updated Emergency Use Authorizations: Bicercna-SARS - EUA Summary Roche Diagnostics Elecsys Anti-SARS-CoV-2 - Fact Sheet for Healthcare Providers Cepheid Xpert Xpress SARS-CoV-2 test - IFU for Labs and Point-of-Care FAQs on Testing for SARS-CoV-2 (Updated) Consumer Information on: The therascreen® BRAF V600E RGQ PCR Kit - P190026 Consumer Information on: The prodisc L Total Disc Replacement  – P050010/S020