CDRH New - May 24, 2021

If your email program has trouble displaying this email, view as a webpage. May 24, 2021 The Center for Devices and Radiological Health (CDRH) posted these new items on FDA.gov on May 21, 2021. To view listings for other dates, see CDRH New - News and Updates. New Emergency Use Authorizations Sienna-Clarity COVID-19 Antigen Rapid Test Cassette (Salofa Oy) LIAISON SARS-CoV-2 TrimericS IgG (DiaSorin, Inc.) Reissued Emergency Use Authorizations LetsGetChecked Coronavirus (COVID-19) Test (LetsGetChecked, Inc.) Kroger Health COVID-19 Test Home Collection Kit (The Kroger Co.) Elecsys Anti-SARS-CoV-2 (Roche Diagnostics) Updated Emergency Use Authorizations New York SARS-CoV-2 Real-time Reverse Transcriptase (RT)-PCR Diagnostic Panel (Wadsworth Center, New York State Department of Public Health) Genetron SARS-CoV-2 RNA Test (Genetron Health (Beijing) Co., Ltd.) Biosearch Technologies SARS-CoV-2 Real-Time and End-Point RT-PCR Test (LGC, Biosearch Technologies) Mammography Problems at Advanced Women Imaging in Guttenberg, NJ: FDA Safety Communication Class I Recall: Boston Scientific Corporation Recalls VICI VENOUS STENT System and VICI RDS VENOUS STENT System for Potential of Stent Migration Virtual Town Hall Series - Coronavirus (COVID-19) Test Development and Validation - May 19, 2021 (Added Presentation and Transcript) Notifications and Emergency Use Authorizations: FAQs on Testing for SARS-CoV-2 (Updated)

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