CDRH New - August 13, 2021

If your email program has trouble displaying this email, view as a webpage. August 13, 2021 The Center for Devices and Radiological Health (CDRH) posted these new items on FDA.gov on August 12, 2021. To view listings for other dates, see CDRH New - News and Updates. New Emergency Use Authorizations SelfCheck COVID-19 TaqPath Multiplex PCR (Cleveland Clinic Robert J. Tomsich Pathology and Laboratory Medicine Institute) Amazon Multi-Target SARS-CoV-2 Real-Time RT-PCR DTC Test (STS Lab Holdco (a subsidiary of Amazon.com Services LLC)) Amazon Multi-Target SARS-CoV-2 Real-Time RT-PCR Test (STS Lab Holdco (a subsidiary of Amazon.com Services LLC)) Reissued Emergency Use Authorizations Amazon Real-Time RT-PCR DTC Test for Detecting SARS-CoV-2 (STS Lab Holdco (a subsidiary of Amazon.com Services LLC)) BinaxNOW COVID-19 Antigen Self Test (Abbott Diagnostics Scarborough, Inc.) SGTi-flex COVID-19 IgG (Sugentech, Inc.) ADVIA Centaur SARS-CoV-2 IgG (sCOVG) (Siemens Healthcare Diagnostics Inc.) CovAb SARS-CoV-2 Ab Test (Diabetomics, Inc.) Baxter Healthcare Recalls Dose IQ Software Version 9.0.x, Used with Spectrum IQ Infusion Pumps, for Software Defect That May Improperly Configure Drug and Fluid Delivery (Updated) Discussion Paper: Strengthening Cybersecurity Practices Associated with Servicing of Medical Devices: Challenges and Opportunities (Updated) Class I Recall: Baxter Healthcare Recalls Dose IQ Software Version 9.0.x, Used with Spectrum IQ Infusion Pumps, for Software Defect That May Improperly Configure Drug and Fluid Delivery 2018-2020 Strategic Priorities - Accomplishments

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