|Trade Name||GEN-PROBE(R) AMPLIFIED MYCOBACTERIUM TUBERCULOSIS DIRECT TEST (MTD TEST)|
|Generic Name||target amplification test for the direct detection of mycobacterium tuberculosis|
|Supplement Type||normal 180 day track|
|Supplement Reason|| postapproval protocol or modification to a protocol|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for modified stability testing specifications, and a modified quality control procedure for monitoring acceptability of specimen processing reagents. The supplement included a protocol for assessing effectiveness of user controls with rrna controls and a stability testing protocol using the 15 minute selection time that were specific conditions for postapproval requirements described in the approval order for p940034/s004.