CDRH New - January 11, 2021

If your email program has trouble displaying this email, view as a webpage. CDRH New January 11, 2021 The Center for Devices and Radiological Health (CDRH) posted these new items on FDA.gov on January 8, 2021. To view listings for other dates, see CDRH New - News and Updates. Re-issued Emergency Use Authorizations Accula SARS-Cov-2 Test (Mesa Biotech Inc.) Xpert Xpress SARS-CoV-2 test (Cepheid) Updated Emergency Use Authorizations ExProbe SARS-CoV-2 Testing Kit (TBG Biotechnology Corp.) OPTI SARS-CoV-2 RT PCR Test (OPTI Medical Systems, Inc.) Genetrack SARS-CoV-2 Molecular Assay (Genetrack Biolabs, Inc.) Exhibit 1: Authorized Imported, Non-NIOSH Disposable Filtering Facepiece Respirators (FFR) EUA Authorized Serology Test Performance (Updated) Consumer Information on: ActaStim-S Spine Fusion Stimulator - P190030 Genetic Variants of SARS-CoV-2 May Lead to False Negative Results with Molecular Tests for Detection of SARS-CoV-2 - Letter to Clinical Laboratory Staff and Health Care Providers FDA News Release: FDA Issues Alert Regarding SARS-CoV-2 Viral Mutation to Health Care Providers and Clinical Laboratory Staff Notifications and Emergency Use Authorizations: FAQs on Testing for SARS-CoV-2 (Updated) FAQs on Viral Transport Media During COVID-19 (Updated)

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