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Zdrowie i gospodarka · 19/03/2012

FDA Proposes Changes to Diagnostic Devices for Tuberculosis Detection

The FDA is proposing to reclassify nucleic acid-based diagnostic devices for detecting Mycobacterium tuberculosis complex from class III to class II, allowing for faster market approval and use as an aid in diagnosing pulmonary tuberculosis.

Source: Federal Register — Food and Drug AdministrationOpen original release →