CDRH New - October 13, 2021

If your email program has trouble displaying this email, view as a webpage. October 13, 2021 The Center for Devices and Radiological Health (CDRH) posted these new items on FDA.gov on October 12, 2021. To view listings for other dates, see CDRH New - News and Updates. New Emergency Use Authorizations Cleveland Clinic Robert J. Tomsich Pathology and Laboratory Medicine Institute PerkinElmer, Inc. Quest Diagnostics Infectious Disease, Inc. Quest Diagnostics Collection Kit for COVID-19 10/08/2021 Emergency Use Authorization of COVID-19 Tests: Independent Assessment of the FDA's Response Updated Emergency Use Authorizations EUROIMMUN US, Inc. DiaSorin Inc. Re-issued Emergency Use Authorizations Quest Diagnostics Infectious Disease, Inc. Quest Diagnostics HA SARS-CoV-2 Assay  Quest Diagnostics RC SARS-CoV-2 Assay  Quest Diagnostics PF SARS-CoV-2 Assay  24 Hour Summary for October 6, 2021 Patient Engagement Advisory Committee Meeting Potential for Medication Overdose with ENFit Low Dose Tip Syringe: FDA Safety Communication

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