|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 ABPLIFIED MYCOBACTERIUM TUBERCULOSIS DIRECT TEST|
|Classification Name||system, nucleic acid amplification, mycobacterium tuberculosis complex|
|Generic Name||system, nucleic acid amplification, mycobacterium tuberculosis complex|
|Supplement Type||30-day notice|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Change to qc specification for the release of the amplification reagent.