CDRHNew - News and Updates | FDA

CDRHNew - News and Updates | FDA

CDRH New May 26, 2020 The Center for Devices and Radiological Health (CDRH) posted these new items on FDA.gov on May 22, 2020. To view listings for other dates, see CDRH New - News and Updates.

New Emergency Use Authorization BioCore Co. Ltd. SolGent Co. Ltd. Seasun Biomaterials, Inc. P23 Labs, LLC. Gowns and Other Apparel Exact Sciences SARS-CoV-2 (N gene detection) Test Express Gene 2019-nCoV RT-PCR Diagnostic Panel Avera Institute for Human Genetics SARS-CoV-2 Assay Updated Emergency Use Authorization P23 Labs TaqPath SARS-CoV-2 Assay - IFU Home Collect Presentation and Transcript added to: Virtual Town Hall - 3D Printed Swabs FAQs on Testing for SARS-CoV-2 (Updated) Medical Gloves for COVID-19