CDRH New - February 1, 2022

If your email program has trouble displaying this email, view as a webpage. February 1, 2022 The Center for Devices and Radiological Health (CDRH) posted these new items on FDA.gov on January 31, 2022. To view listings for other dates, see CDRH New - News and Updates. Reissued Emergency Use Authorizations SalivaDirect (Yale School of Public Health, Department of Epidemiology of Microbial Diseases)  Amazon Real-Time RT-PCR DTC Test for Detecting SARS-CoV-2 (STS Lab Holdco (a subsidiary of Amazon.com Services LLC)) Amazon Multi-Target SARS-CoV-2 Real-Time RT-PCR DTC (STS Lab Holdco (a subsidiary of Amazon.com Services LLC)) COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) (Healgen Scientific LLC) InteliSwab COVID-19 Rapid Test Rx (OraSure Technologies, Inc.) InteliSwab COVID-19 Rapid Test (OraSure Technologies, Inc.) InteliSwab COVID-19 Rapid Test Pro (OraSure Technologies, Inc.) SCoV-2 Ag Detect Rapid Self-Test (InBios International Inc.) Revised Emergency Use Authorization Amazon Multi-Target SARS-CoV-2 Real-Time RT-PCR Test (STS Lab Holdco (a subsidiary of Amazon.com Services LLC)) Amazon Real-Time RT-PCR Test for Detecting SARS-CoV-2 (STS Lab Holdco (a subsidiary of Amazon.com Services LLC)) Color COVID-19 Self-Swab Collection Kit (Color Health, Inc.) Color COVID-19 Self-Swab Collection Kit DTC (Color Health, Inc.) Psoma COVID-19 RT Test (Psomagen, Inc.) Updated Emergency Use Authorizations SARS-CoV-2 MassArray Test (National Jewish Health) CDRH 2021 Annual Report

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