CDRH New - November 30, 2020

U.S. Food and Drug Administration sent this bulletin at 11/30/2020 09:05 AM EST

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CDRH New

November 30, 2020

The Center for Devices and Radiological Health (CDRH) posted these new items on FDA.gov on November 27, 2020. To view listings for other dates, see CDRH New - News and Updates.

New Emergency Use Authorizations
- COVID-SeroKlir, Kantaro Semi-Quantitative SARS-CoV-2 IgG Antibody Kit (Kantaro Biosciences, LLC)
Re-issued Emergency Use Authorizations
- SARS-CoV-2 RT-PCR Assay (Stanford Health Care Clinical Virology Laboratory)
Updated Emergency Use Authorizations
- Exhibit 1: Authorized Imported, Non-NIOSH Disposable Filtering Facepiece Respirators (FFR)

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