CDRH New - August 23, 2021

If your email program has trouble displaying this email, view as a webpage. August 23, 2021 The Center for Devices and Radiological Health (CDRH) posted these new items on FDA.gov on August 20, 2021. To view listings for other dates, see CDRH New - News and Updates. Reissued Emergency Use Authorization BioCore 2019-nCoV Real Time PCR Kit (INVITES BIOCORE CO., LTD.) Alinity m SARS-CoV-2 assay (Abbott Molecular Inc.) Infinity BiologiX TaqPath SARS-CoV-2 Assay (Infinity BiologiX LLC) IntelliPlex SARS-CoV-2 Detection Kit (PlexBio Co., Ltd.) Access SARS-CoV-2 IgG II (Beckman Coulter, Inc.) Updated Emergency Use Authorization Amazon Multi-Target SARS-CoV-2 Real-Time RT-PCR DTC Test (STS Lab Holdco (a subsidiary of Amazon.com Services LLC) BD Vacutainer Plus Citrate Plasma Tubes (UK Manufacturing Site) (Becton, Dickinson and Company) 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) Class I Recall: Cardinal Health Recalls Argyle UVC Insertion Tray Due to Missing Instructions for Use for the Safety Scalpel N11 UPDATE: Caution with Robotically-Assisted Surgical Devices in Mastectomy: FDA Safety Communication

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