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Tag: Respiratory Infection

FDA Expands Use of Device to Detect both Viral and Bacterial Causes of Respiratory Infection

510(k), CGMP, FDA, Medical Devices, Respiratory InfectionFDA

On May 15, 2012, the U.S. Food and Drug Administration (“FDA”) announced the clearance of expanded uses for the FilmArray Respiratory Panel, a medical device used to detect causes of respiratory infection. Manufactured by Idaho Technology, Inc., the device is …

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