|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||AMPLIFED MYCOBACTERIUM TUBERCULOSIS DIRECTOR (MTD) TEST|
|Supplement Type|| Special Supplement|
|Supplement Reason|| labeling change - instructions|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for additional text under warnings: "sediments prepared using alpha-tec systems, inc. Nac-pac(tm) xpr-plus(tm) a. F. B. Processing buffer have been shown to interfere with amplification. ".