CDRH New - June 23, 2021

If your email program has trouble displaying this email, view as a webpage. June 23, 2021 The Center for Devices and Radiological Health (CDRH) posted these new items on FDA.gov on June 22, 2021. To view listings for other dates, see CDRH New - News and Updates. New Emergency Use Authorizations WREN Laboratories COVID-19 PCR Test DTC (WREN Laboratories LLC) WREN Laboratories COVID-19 Saliva Test Collection Kit DTC (WREN Laboratories LLC) cobas SARS-CoV-2 Nucleic acid test for use on the cobas Liat System (cobas SARS-CoV-2) (Roche Molecular Systems) ADVIA Centaur SARS-CoV-2 IgG (sCOVG) (Siemens Healthcare Diagnostics Inc.) Reissued Emergency Use Authorizations BioFire COVID-19 Test (BioFire Defense, LLC) MobileDetect Bio BCC19 (MD-Bio BCC19) (MobileDetect Bio Inc.) WREN Laboratories COVID-19 PCR Test (WREN Laboratories LLC) Evaluation of Automatic Class III Designation (De Novo) Summaries (DEN200031 added)

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