CDRHNew - News and Updates | FDA

CDRHNew - News and Updates | FDA

CDRH New May 18, 2020 The Center for Devices and Radiological Health (CDRH) posted these new items on FDA.gov on May 15-16, 2020. To view listings for other dates, see CDRH New - News and Updates.

New Emergency Use Authorizations Aptima SARS-CoV-2 assay (Hologic, Inc.) NeoPlex COVID-19 Detection Kit (GeneMatrix, Inc.) VSMS Patch (G Medical Innovations, Ltd.) Everlywell COVID-19 Test Home Collection Kit (Everlywell, Inc.) Fulgent COVID-19 by RT-PCR Test (Fulgent Therapeutics, LLC) Assurance SARS-CoV-2 Panel (Assurance Scientific Laboratories) Updated Emergency Use Authorizations SARS-CoV-2 IgG assay (Abbott Laboratories Inc.) Contacts for Medical Devices During the COVID-19 Pandemic FAQs on Testing for SARS-CoV-2 (Updated)