|Trade Name||GEN-PROBE(R) AMPLIFIED MYCOBACTERIUM TUBERCULOSIS DIRECT TEST (MTD TEST)|
|Classification Name||system, nucleic acid amplification, mycobacterium tuberculosis complex|
|Generic Name||target amplification test for the direct detection of mycobacterium tuberculosis|
|Supplement Type||normal 180 day track|
|Supplement Reason|| labeling change - other|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for physician prescribing information to be considered a component of the labeling for mtd. At this time there are no provisions for "in vitro" device labeling other than prescribed 21 cfr 809. 10 (b); however, the physician prescribing information may be used as promotional and advertising material.