|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(R) AMPLIFIED MYCOBACTERIUM TUBERCULOSIS DIRECT TEST (MTD TEST)|
|Supplement Type||normal 180 day track|
|Supplement Reason|| postapproval study protocol - ode/oir|
|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.