CDRH New - April 9, 2020

The Center for Devices and Radiological Health (CDRH) posted these new items on FDA.gov on April 8, 2020. To view listings for other dates, see CDRH New - News and Updates.

New Emergency Use Authorizations: QuantiVirus SARS-CoV-2 Test Kit SARS-CoV-2 PCR Assay (Stanford Health Care Clinical Virology Laboratory) BD SARS-CoV-2 Reagents for BD MAX System (Becton, Dickinson and Company) Updated Emergency Use Authorizations: Appendix B: Authorized Ventilators, Ventilator Tubing Connectors, and Ventilator Accessories Presentation and Transcript added for Town Hall Series - Immediately in Effect Guidance on Coronavirus (COVID-19) Diagnostic Tests - April 1, 2020 Consumer Information on: VENOUS WALLSTENT - P980033/S050