CDRH New - February 1, 2021

If your email program has trouble displaying this email, view as a webpage. CDRH New February 1, 2021 The Center for Devices and Radiological Health (CDRH) posted these new items on FDA.gov on January 29, 2021. To view listings for other dates, see CDRH New - News and Updates. Reissued Emergency Use Authorizations Real-Time Fluorescent RT-PCR Kit for Detecting SARS-CoV-2 (BGI Genomics Co. Ltd) Updated Emergency Use Authorizations Xpert Xpress SARS-CoV-2/Flu/RSV (Cepheid) MassARRAY SARS-CoV-2 Panel (Agena Bioscience, Inc.) BayCare SARS-CoV-2 RT PCR Assay (BayCare Laboratories, LLC) Alpha Genomix TaqPath SARS-CoV-2 Combo Assay (Alpha Genomix Laboratories) SARS-CoV-2 Assay (AIT Laboratories) Exhibit 1: Authorized Imported, Non-NIOSH Disposable Filtering Facepiece Respirators (FFR) February 2021 Dates Announced for the Virtual Town Hall Series for Test Developers on Coronavirus (COVID-19) Penumbra's Recall of the JET 7 Reperfusion Catheter Due to Distal Tip Damage Notifications and Emergency Use Authorizations: FAQs on Testing for SARS-CoV-2 (Updated) Removal Lists of Tests that Should No Longer Be Used and/or Distributed for COVID-19: FAQs on Testing for SARS-CoV-2 (Updated)

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