CDRH New - August 1, 2022

If your email program has trouble displaying this email, view as a webpage. August 1, 2022 The Center for Devices and Radiological Health (CDRH) posted these new items on FDA.gov on July 29, 2022. To view listings for other dates, see CDRH New - News and Updates. Reissued Emergency Use Authorizations Predicine SARS-CoV-2 RT-PCR Test (Predicine, Inc.) Revogene SARS-CoV-2 (Meridian Bioscience, Inc.) Omnia SARS-CoV-2 Antigen Test (Qorvo Biotechnologies, LLC.: For Qorvo Biotechnologies, LLC.) Revised Emergency Use Authorizations Labcorp Seasonal Respiratory Virus RT-PCR Test (Laboratory Corporation of America (Labcorp)) Labcorp Seasonal Respiratory Virus RT-PCR DTC Test (Laboratory Corporation of America (Labcorp)) Labcorp SARS-CoV-2 & Influenza A/B Assay (Laboratory Corporation of America (Labcorp)) Lucira CHECK-IT COVID-19 Test Kit (Lucira Health, Inc.) Lucira COVID-19 All-In-One Test Kit (Lucira Health, Inc.)

Follow us on Twitter at @FDADeviceInfo Manage Subscriptions  |  Unsubscribe All  |  Help

This email was sent to ooseims.archieves@blogger.com 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