CDRHNew - News and Updates | FDA

CDRHNew - News and Updates | FDA

CDRH New September 2, 2020 The Center for Devices and Radiological Health (CDRH) posted these new items on FDA.gov on September 1, 2020. To view listings for other dates, see CDRH New - News and Updates.

New Emergency Use Authorizations T2SARS-CoV-2 Panel (T2 Biosystems, Inc.) MiraDx SARS-CoV-2 RT-PCR assay (MiraDx) SARS-CoV-2 DETECTR Reagent Kit (Mammoth Biosciences, Inc.) BayCare SARS-CoV-2 RT PCR Assay (BayCare Laboratories, LLC) TBG SARS-CoV-2 IgG / IgM Rapid Test Kit (TBG Biotechnology Corp.) COVID-19 ELISA pan-Ig Antibody Test (University of Arizona Genetics Core for Clinical Services) Updated Emergency Use Authorizations Ventilators and Ventilator Accessories EUAs CRSP SARS-CoV-2 Real-time Reverse Transcriptase (RT)-PCR Diagnostic Assay (Clinical Research Sequencing Platform (CRSP), LLC at the Broad Institute of MIT and Harvard) (Revision, HCP, Patients, EUA Summary) RightSign COVID-19 IgG/IgM Rapid Test Cassette (Hangzhou Biotest Biotech Co., Ltd.) (Revision, IFU) AMPIPROBE SARS-CoV-2 Test System (Enzo Life Sciences, Inc.) (IFU) BioCheck SARS-CoV-2 IgG and IgM Combo Test (BioCheck, Inc.) (IFU) MQSA National Statistics FAQs on Testing for SARS-CoV-2 (Updated) FAQs on Viral Transport Media During COVID-19 (Updated) Consumer Information on: Kendall™ Multifunction Defibrillation Electrodes - P190007