|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 TEST)|
|Classification Name||system, nucleic acid amplification, mycobacterium tuberculosis complex|
|Supplement Type|| Special Supplement|
|Supplement Reason|| process change - other|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for changes to the relative light units (rlu) specification for the 0. 2-0. 3 mm washed glass beads (part no. 101321) and filled lysing tubes (part no. 102606).