CDRH New - August 10, 2021

If your email program has trouble displaying this email, view as a webpage. August 10, 2021 The Center for Devices and Radiological Health (CDRH) posted these new items on FDA.gov on August 9, 2021. To view listings for other dates, see CDRH New - News and Updates. Revoked Emergency Use Authorizations Guardant-19 (Guardant Health, Inc.) New Emergency Use Authorizations QIAreach SARS-CoV-2 Antigen Test (QIAGEN GmbH) Updated Emergency Use Authorizations CareStart COVID-19 Antigen Home Test (Access Bio, Inc.) ACON SARS-CoV-2 IgG/IgM Rapid Test (ACON Laboratories) Reissued Emergency Use Authorizations CareStart COVID-19 IgM/IgG (Access Bio, Inc.) Influenza SARS-CoV-2 (Flu SC2) Multiplex Assay (Centers for Disease Control and Prevention (CDC)) SDNA-1000 Saliva Collection Device (Spectrum Solutions LLC) TaqPath COVID-19, FluA, FluB Combo Kit (Thermo Fisher Scientific)

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