Zdrowie i gospodarka · 19/06/2013

FDA Proposes Reclassification of Nucleic Acid-Based Devices for Tuberculosis Detection

The FDA is proposing to reclassify nucleic acid-based in vitro diagnostic devices for detecting Mycobacterium tuberculosis complex in respiratory specimens from class III to class II, with the goal of making these devices more accessible for diagnosing pulmonary tuberculosis.