CDRH New - May 26, 2021

If your email program has trouble displaying this email, view as a webpage. May 26, 2021 The Center for Devices and Radiological Health (CDRH) posted these new items on FDA.gov on May 25, 2021. To view listings for other dates, see CDRH New - News and Updates. New Emergency Use Authorizations Quaeris SARS-CoV-2 Assay (Harvard University Clinical Laboratory (HUCL)) ADEXUSDx COVID-19 Test (NOWDiagnostics, Inc.) Re-issued Emergency Use Authorizations Bio-Speedy Direct RT-qPCR SARS-CoV-2 (Bioeksen R&D Technologies Inc.) COVID-19 RT-PCR Peptide Nucleic Acid (PNA) kit (BioTNS Co. Ltd.) Aptima SARS-CoV-2 assay (Hologic, Inc.) Updated Emergency Use Authorizations Smart Detect SARS-CoV-2 rRT-PCR Kit (InBios International, Inc.) South Korea's Response to COVID-19 Consumer Information on: VENTANA MMR RxDx Panel – P200019 Webinar on Implanted BCI Devices for Patients with Paralysis or Amputation - Non-clinical Testing and Clinical Considerations Final Guidance - July 29, 2021 Notifications and Emergency Use Authorizations: FAQs on Testing for SARS-CoV-2 (Updated) FAQs on Viral Transport Media During COVID-19 (Updated)

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