CDRH New - December 28, 2020

If your email program has trouble displaying this email, view as a webpage. CDRH New December 28, 2020 The Center for Devices and Radiological Health (CDRH) posted these new items on FDA.gov on December 23, 2020. To view listings for other dates, see CDRH New - News and Updates. New Emergency Use Authorizations Solana SARS-CoV-2 Assay (Quidel Corporation) Simoa Semi-Quantitative SARS-CoV-2 IgG Antibody Test (Quanterix Corporation) Updated Emergency Use Authorizations Xpert Omni SARS-CoV-2 (Cepheid) BioFire Respiratory Panel 2.1-EZ (RP2.1-EZ) (BioFire Diagnostics, LLC) EmpowerDX At-Home COVID-19 PCR Test Kit (Clinical Enterprise, Inc.) Ellume COVID-19 Home Test (Ellume Limited) Alinity m SARS-CoV-2 assay (Abbott Molecular Inc.) Supplies of Medical Devices for COVID-19: Frequently Asked Questions Medical Device Shortages During the COVID-19 Public Health Emergency (Updated) Medical Device Types to Help Determine Section 506J Notification Obligations (Updated) 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) Class I Recall: Cook Medical Recalls Flexor Check-Flo Introducers and Flexor Tuohy-Borst Side-Arm Introducers Due to Separation in Device Consumer Information posted for MiniMed 770G System - P160017/S076

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