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CDRH New - March 7, 2023

US FDA sent this email to their subscribers on March 7, 2023.


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If your email program has trouble displaying this email, view as a webpage. Y U.S. DRHNew cb:@; Bookmark and Share MARCH 7, 2023 The Center for Devices and Radiological Health (CDRH) posted these new items on FDA.gov on March 6, 2023. To view listings for other dates, see CDRH New - News and Updates. * Revised Emergency Use Authorizations * Celltrion DiaTrust COVID-19 Ag Rapid Test (Celltrion USA, Inc.) * Celltrion DiaTrust COVID-19 Ag Home Test (Celltrion USA, Inc.) * Sofia SARS Antigen FIA (Quidel Corporation) * VITROS Immunodiagnostic Products SARS-CoV-2 Antigen Reagent Pack (Ortho Clinical Diagnostics, Inc.) * Omnia SARS-CoV-2 Antigen Test (Qorvo Biotechnologies, LLC.) * Reissued Emergency Use Authorizations * Umbrella EUA for Surgical Masks * Face Masks, Barrier Face Coverings, Surgical Masks, and Respirators for COVID-19 (Updated) * Federal Register: Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee Follow us on Twitter at @FDADeviceInfo twitterfacebookyoutubeLinkedIn Manage Subscriptions  |   |  Help ---------------------------------------------------------------------------------------------------------------------------------- This email was sent to [email protected] using GovDelivery Communications Cloud on behalf of: U.S. Food and Drug Administration ·  10903 New Hampshire Ave · Silver Spring, MD ·  20993-0002 ·  1-888-INFO-FDA GovDelivery logo gOVDELlVERY
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