CDRH New - July 20, 2021

If your email program has trouble displaying this email, view as a webpage. July 20, 2021 The Center for Devices and Radiological Health (CDRH) posted these new items on FDA.gov on July 19, 2021. To view listings for other dates, see CDRH New - News and Updates. Reissued Emergency Use Authorizations PerkinsElmer New Coronavirus Nucleic Acid Detection Kit ISPM Labs, LLC dbaCapstone Healthcare Revised Emergency Use Authorizations AMPIPROBE SARS-CoV-2 Test (Enzo Life Sciences, Inc.) Ambry COVID-19 RT-PCR Test (Ambry Genetics Laboratory) CareSTart COVID-19 Antigen Test (Access Bio, Inc.) Updated Emergency Use Authorizations RealStar SARS-CoV-2 RT-PCR Kits (Altona Diagnostics GmbH) KimForest SARS-CoV-2 Detetion Kit v1 (KimForest Enterprise Co., Ltd.) Updated Emergency Use Authorizations Appendix A: Authorized Surgical Masks Evaluation of Automatic Class III Designation (De Novo) Summaries (DEN190043 added)

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