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Consumer Information on: iPro2 Continuous Glucose Monitoring System
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Transcripts posted for July 21-22, 2016 Clinical Chemistry and Clinical Toxicology Devices Panel of the Medical Devices Advisory Committee meeting
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FDA Recommends Health Care Facilities Stop Using Custom Ultrasonics’ System 83 Plus Automated Endoscope Reprocessors (AERs) for Reprocessing Duodenoscopes; These Reprocessors Remain Available to Reprocess Other Flexible Endoscopes: FDA Safety Comm.
August 17, 2016 Audiences: Personnel working in endoscopy reprocessing units in health care facilities Health care providers that perform endoscopic procedures Infection Control practitioners Risk Managers Purchasers and other Hospital Administration staff Medical Specialties: Infection Control, Gastroenterology, Pulmonology, General Surgery, Anesthesiology, Internal Medicine Product: All Custom Ultrasonics’ System 83 Plus Automated Endoscope Reprocessors (AERs) used…
Emergency Use Authorizations: ZIKV Detect™ IgM Capture ELISA (InBios International, Inc.)
On February 26, 2016, the FDA issued an Emergency Use Authorization (EUA) to authorize the emergency use of Centers for Disease Control and Prevention’s (CDC) Zika Immunoglobulin M (IgM) Antibody Capture Enzyme-Linked Immunosorbent Assay (Zika MAC-ELISA) for the presumptive detection of Zika virus-specific IgM in human sera or cerebrospinal fluid (CSF) that is submitted alongside…
24 Hour Summary posted for August 10, 2016 Clinical Chemistry and Clinical Toxicology Devices Panel of the Medical Devices Advisory Committee meeting
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Check the CDRH Customer Satisfaction Results
This page provides real time results for CDRH’s customer satisfaction survey for the current rating period. About the Survey: On June 16, 2014, CDRH launched the Customer Satisfaction survey. The survey was revised between December 14, 2015 and February 1, 2016. CDRH measures customer satisfaction in six months intervals. CDRH Customer Satisfaction Rating: Results below…
Evaluation of Automatic Class III Designation (De Novo) Summaries (DEN 140024 and DEN140040 added)
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Meeting materials posted for August 16, 2016 Microbiology Devices Panel of the Medical Devices Advisory Committee meeting
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Agenda posted for August 16, 2016 Microbiology Devices Panel of the Medical Devices Advisory Committee meeting
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