CDRH New - February 11, 2022

If your email program has trouble displaying this email, view as a webpage. February 11, 2022 The Center for Devices and Radiological Health (CDRH) posted these new items on FDA.gov on February 10, 2022. To view listings for other dates, see CDRH New - News and Updates. New Emergency Use Authorizations Advanta Dx COVID-19 EASE Assay (Fluidigm Corporation) UOL COVID-19 Test (Uh-Oh Labs Inc.) Reissued Emergency Use Authorizations CLINITEST Rapid COVID-19 Antigen Self-Test (Siemens Healthineers) Updated Emergency Use Authorizations Elecsys Anti-SARS-CoV-2 S (Roche Diagnostics, Inc.) Anti-SARS-CoV-2 ELISA (IgG) (EUROIMMUN US Inc.) Cue COVID-19 Test for Home and Over The Counter (OTC) Use (Cue Health Inc.) Appendix A: Authorized Molecular-Based Laboratory Developed Tests for Detection of Nucleic Acid from SARS-CoV-2 - Removal of SARS-CoV-2 Test (Biocerna)  Revised Emergency Use Authorizations Alinity m Resp-4-Plex (Abbott Molecular Inc.) Revoked Emergency Use Authorization LifeHope 2019-nCoV Real-Time RT-PCR Diagnostic Panel (LifeHope Labs)

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