CDRH New - February 17, 2022

If your email program has trouble displaying this email, view as a webpage. February 17, 2022 The Center for Devices and Radiological Health (CDRH) posted these new items on FDA.gov on February 16, 2022. To view listings for other dates, see CDRH New - News and Updates. Reissued Emergency Use Authorizations BD SARS-CoV-2 Reagents for BD MAX System (Becton, Dickinson and Company (BD)) HDPCR SARS-CoV-2 Assay (ChromaCode Inc.) Updated Emergency Use Authorizations LYHER Novel Coronavirus (2019-nCoV) IgM/IgG Antibody Combo Test Kit (Colloidal Gold) (Hangzhou Laihe Biotech Co., Ltd.) cobas SARS-CoV-2 (Roche Molecular Systems, Inc.) cobas SARS-CoV-2 & Influenza A/B (Roche Molecular Systems, Inc.) COVID-Flu Multiplex Assay (Exact Sciences Laboratories) Revised Emergency Use Authorizations Quick SARS-CoV-2rRT-PCR Kit (Zymo Research Corporation) Revoked Emergency Use Authorization Omni COVID-19 Assay by RT-PCR (Omnipathology Solutions Medical Corporation) Virtual Town Hall Series - Coronavirus (COVID-19) Test Development and Validation - February 23, 2022 Federal Register: Device Good Manufacturing Practice Advisory Committee

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