CDRH New - May 1, 2020

The Center for Devices and Radiological Health (CDRH) posted these new items on FDA.gov on April 30, 2020. To view listings for other dates, see CDRH New - News and Updates.

New Emergency Use Authorizations: LabGun COVID-19 RT-PCR Kit (LabGenomics Co., Ltd) Rheonix COVID-19 MDx Assay (Rheonix, Inc.) LabGun COVID-19 RT-PCR Kit (LabGenomics Co., Ltd.) Platelia SARS-CoV-2 Total Ab assay (Bio-Rad Laboratories) Updated Emergency Use Authorizations: Appendix B-Ventilators Xpert Xpress SARS-CoV-2 test (Cepheid) VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Reagent Pack (Ortho-Clinical Diagnostics, Inc.) NOTICE OF MEETING POSTPONEMENT: June 9, 2020 - Ophthalmic Devices Panel of the Medical Devices Advisory Committee Class I Recall: Vascular Solutions, Inc. Recalls Langston Dual Lumen Catheter Due to Risk of Separation During Use FAQs on Diagnostic Testing for SARS-CoV-2 (Updated)