|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||QUANTIFERON-TB GOLD|
|Classification Name||test, immunity, cell mediated, mycobacterium tuberculosis|
|Supplement Type|| Special Supplement|
|Supplement Reason|| labeling change - minor|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for lableing change to the wording of the interpretation of the test to remove ambiguity and enhance safe use.