CDRH New - March 24, 2021

If your email program has trouble displaying this email, view as a webpage. March 24, 2021 The Center for Devices and Radiological Health (CDRH) posted these new items on FDA.gov on March 23, 2021. To view listings for other dates, see CDRH New - News and Updates. New Emergency Use Authorizations Access SARS-CoV-2 IgG II (Beckman Coulter, Inc.) Reissued Emergency Use Authorizations Diazyme DZ-Lite SARS-CoV-2 IgG CLIA Kit (Diazyme Laboratories, Inc.) iC SARS-CoV2 Test (Tempus Labs, Inc.) Updated Emergency Use Authorizations LumiraDx SARS-CoV-2 RNA STAR Complete (LumiraDx UK Ltd.) Color SARS-CoV-2 RT-LAMP Diagnostic Assay DTC (Color Health, Inc.) Catalog of Regulatory Science Tools to Help Assess New Medical Devices (Updated) Notifications and Emergency Use Authorizations: FAQs on Testing for SARS-CoV-2 (Updated) Removal Lists of Tests that Should No Longer Be Used and/or Distributed for COVID-19: FAQs on Testing for SARS-CoV-2 (Updated) FAQs on Viral Transport Media During COVID-19 (Updated) Federal Register: Medical Devices: Availability of Safety and Effectiveness Summaries for Premarket Approval Applications

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