CDRH New - December 14, 2021

U.S. Food and Drug Administration sent this bulletin at 12/14/2021 08:40 AM EST

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U.S. Food and Drug Administration - CDRH New

December 14, 2021

The Center for Devices and Radiological Health (CDRH) posted these new items on FDA.gov on December 13, 2021. To view listings for other dates, see CDRH New - News and Updates.

Revised Emergency Use Authorizations
- PerkinElmer New Coronavirus Nucleic Acid Detection Kit (PerkinElmer, Inc.)
- BD Veritor System for Rapid Detection of SARS-CoV-2 (Becton, Dickinson and Company (BD))
Updated Emergency Use Authorizations
- IDS SARS-CoV-2 IgG (Immunodiagnostic Systems Ltd.)
Revoked Emergency Use Authorizations
- qSARS-CoV-2 IgG/IgM Rapid Test (Cellex Inc.)

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