CDRH New - December 2, 2020

If your email program has trouble displaying this email, view as a webpage. CDRH New December 2, 2020 The Center for Devices and Radiological Health (CDRH) posted these new items on FDA.gov on December 1, 2020. To view listings for other dates, see CDRH New - News and Updates. New Emergency Use Authorizations Innovita 2019-nCoV Ab Test (Colloidal Gold) (Innovita (Tangshan) Biological Technology Co., Ltd.) Updated Emergency Use Authorizations Infinity BiologiX TaqPath SARS-CoV-2 Assay (Infinity BiologiX LLC) MassARRAY SARS-CoV-2 Panel (Agena Bioscience, Inc.) Exhibit 1: Authorized Imported, Non-NIOSH Disposable Filtering Facepiece Respirators (FFR) Class I Recall: Baxter Healthcare Recalls Baxter SIGMA Spectrum Infusion Pumps with Master Drug Library (Versions 6 and 8) and Spectrum IQ Infusion Systems with Dose IQ Safety Software Due to Unplanned Shutdown Issues Presentation Slides added to Virtual Public Meeting - Medical Device User Fee Amendments for Fiscal Years 2023 Through 2027 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) FAQs on Viral Transport Media During COVID-19 (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