CDRH New - July 12, 2021

If your email program has trouble displaying this email, view as a webpage. July 12, 2021 The Center for Devices and Radiological Health (CDRH) posted these new items on FDA.gov on July 9, 2021. To view listings for other dates, see CDRH New - News and Updates. New Emergency Use Authorization VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Quantitative Reagent Pack used in combination with the VITROS Immunodiagnostic Products Anti- SARS-CoV-2 IgG Quantitative Calibrator (Ortho-Clinical Diagnostics, Inc.) TaqPath COVID-19 RNase P Combo Kit 2.0 (Thermo Fisher Scientific Inc.) ellume.lab COVID Antigen Test (Ellume Limited) Reissued Emergency Use Authorizations Quaeris SARS-CoV-2 Assay (Harvard University Clinical Laboratory (HUCL)) Updated Emergency Use Authorizations ViroKey SARS-CoV-2 RT-PCR Test v2.0 (Vela Operations Singapore Pte. Ltd.) SARS-CoV-2 DETECTR Reagent Kit (Mammoth Biosciences, Inc.) cobas SARS-CoV-2 & Influenza A/B (Roche Molecular Systems, Inc.) Notifications and Emergency Use Authorizations: FAQs on Testing for SARS-CoV-2 (Updated)

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