Tag Archive: de novo classification

Jan 16

FDA Permits Marketing of Device Capable of Testing for 11 Causes of Infectious Gastroentiritis

On January 14, 2013, the U.S. Food and Drug Administration (FDA) announced that for the first time it will permit marketing for a new diagnostic test that has the ability to simultaneously detect up to eleven (11) prevalent bacterial, viral, and parasitic causes for infectious gastroenteritis from a single sample from a patient. The FDA’s …

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