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  • Title: Microbiology devices; reclassification of nucleic acid-based systems for mycobacterium tuberculosis complex in respiratory specimens. Final rule.
    Author: Food and Drug Administration, HHS.
    Journal: Fed Regist; 2014 May 30; 79(104):31023-8. PubMed ID: 24881095.
    Abstract:
    The Food and Drug Administration (FDA) is reclassifying nucleic acid-based in vitro diagnostic devices for the detection of Mycobacterium tuberculosis complex in respiratory specimens from class III (premarket approval) into class II (special controls). FDA is also issuing the special controls guideline entitled ''Class II Special Controls Guideline: Nucleic Acid-Based In Vitro Diagnostic Devices for the Detection of Mycobacterium tuberculosis Complex in Respiratory Specimens.'' These devices are intended to be used as an aid in the diagnosis of pulmonary tuberculosis.
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