|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||real-time process|
|Supplement Reason|| labeling change - indications/instructions/shelf life/tradename|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for modification of the enzyme dilution buffer and tentatie reconstituted stability (pending completion of real-time studies) of the enzyme reagent for 30 days with an added precaution, and other minor changes to the labeling (including clarification of control testing procedures).