Device |
system, nucleic acid-based, mycobacterium tuberculosis complex, resistance marker, direct specimen |
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 Code | PEU |
Regulation Number |
866.3373
|
Device Class |
2
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