CDRH New - November 2, 2020

If your email program has trouble displaying this email, view as a webpage. CDRH New November 2, 2020 The Center for Devices and Radiological Health (CDRH) posted these new items on FDA.gov on October 30, 2020. To view listings for other dates, see CDRH New - News and Updates. New Emergency Use Authorizations ORAcollect∙RNA OR-100 and ORAcollect∙RNA ORE-100 saliva collection devices (DNA Genotek Inc.) Re-Issued Emergency Use Authorizations OMNIgene·ORAL OM-505 and OME-505 (OMNIgene·ORAL) saliva collection devices (DNA Genotek Inc.) Updated Emergency Use Authorizations NxTAG CoV Extended Panel Assay (Luminex Molecular Diagnostics, Inc.) ARIES SARS-CoV-2 Assay (Luminex Corporation) LetsGetChecked Coronavirus (COVID-19) Test (PrivaPath Diagnostics, Inc.) Illumina COVIDSeq Test (Illumina, Inc.) cobas SARS-CoV-2 & Influenza A/B (Roche Molecular Systems, Inc.) Aptima SARS-CoV-2 assay (Hologic, Inc.) Consumer Update: Pulse Oximeters and Oxygen Concentrators: What to Know About At-Home Oxygen Therapy FDA Publishes List of Essential Medicines, Medical Countermeasures, Critical Inputs Required by Executive Order Virtual Town Hall Series - Coronavirus (COVID-19) Test Development and Validation - November 4, 2020 FAQs on Testing for SARS-CoV-2 (Updated) FAQs on Viral Transport Media During COVID-19 (Updated)

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