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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device system, nucleic acid-based, mycobacterium tuberculosis complex, resistance marker, direct specimen
Regulation Description Nucleic acid-based in vitro diagnostic devices for the detection of Mycobacterium tuberculosis complex (MTB-complex) and the genetic mutations associated with MTB-complex antibiotic resistance in respiratory specimens.
Definition The [test] is intended for use with specimens from patients for whom there is clinical suspicion of tuberculosis (TB) and who have received no antituberculosis therapy, or less than 3 days of therapy. This [test] is intended as an aid in the diagnosis of pulmonary tuberculosis when used in conjunction with clinical and other laboratory findings.
Product CodePEU
Regulation Number 866.3373
Device Class 2

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