CDRH New - June 30, 2021

If your email program has trouble displaying this email, view as a webpage. June 30, 2021 The Center for Devices and Radiological Health (CDRH) posted these new items on FDA.gov on June 29, 2021. To view listings for other dates, see CDRH New - News and Updates. New Emergency Use Authorizations CareStart EZ COVID-19 IgM/IgG (Access Bio, Inc.) Reissued Emergency Use Authorizations CareStart COVID-19 IgM/IgG (Access Bio, Inc.) Revised Emergency Use Authorizations ACON SARS-CoV-2 IgG/IgM Rapid Test (ACON Laboratories, Inc.) COVID-19 Self-Collected Antibody Test System (Symbiotica, Inc.) GeneFinder COVID-19 Plus RealAmp Kit (OSANG Healthcare) cobas SARS-CoV-2 & Influenza A/B Nucleic Acid Test for use on the cobas Liat System (Roche Molecular Systems, Inc.) Updated Emergency Use Authorizations qSanger-COVID-19 Assay (BillionToOne, Inc.) TRUPCR SARS-CoV-2 Kit (3B Blackbio Biotech India Ltd., a subsidiary of Kilpest India Ltd.) ViroKey SARS-CoV-2 RT-PCR Test (Vela Operations Singapore Pte Ltd) PhoenixDx SARS-CoV-2 Multiplex (Trax Management Services Inc.) Clinomics TrioDx RT-PCR COVID-19 Test (Clinomics USA Inc.) Fulgent COVID-19 by RT-PCR Test (Fulgent Therapeutics) cobas SARS-CoV-2 Nucleic acid test for use on the cobas Liat System (cobas SARS-CoV-2) (Roche Molecular Systems) Waiver and Acknowledgment posted for July 14, 2021 Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee Meeting Federal Register: Medical Devices-Exemption From Premarket Notification; Powered Patient Transport, All Other Powered Patient Transport: Correction Federal Register: MedWatch; The Food and Drug Administration Medical Products Reporting Program

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