|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 - instructions|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for changes to the labeling: instructions for use section, specimen collection and handling section, and abbreviated test procedure section for use of the quantiferon® blood collection tubes.