|Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.|
|Trade Name||GEN-PROBE AMPLIFIED MYCOBACTERIUM TUBERCULOSIS DIRECT TEST (MTD)|
|Classification Name||system, nucleic acid amplification, mycobacterium tuberculosis complex|
|Supplement Type||135 review track for 30-day notice|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for a change to a quality control release specification for the enzyme reagent, a component of the mycobacterium tuberculosis direct (mtd) test.