CDRH New - May 19, 2020

CDRH New May 19, 2020 The Center for Devices and Radiological Health (CDRH) posted these new items on FDA.gov on May 18, 2020. To view listings for other dates, see CDRH New - News and Updates.

Updated Emergency Use Authorizations Abbott Laboratories Inc. SARS-CoV-2 IgG assay - IFU Autobio Diagnostics Co. Ltd. Anti-SARS-CoV-2 Rapid Test - IFU, HCP, Recipients Cellex Inc. qSARS-CoV-2 IgG/IgM Rapid Test - IFU, HCP, Patients Roche Diagnostics Elecsys Anti-SARS-CoV-2 - IFU FAQs on Testing for SARS-CoV-2 (Updated)