|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||normal 180 day track|
|Supplement Reason|| design change - minor|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for a change in the formulation of the wash buffer 20x concentrate.