|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-IN-TUBE|
|Classification Name||test, immunity, cell mediated, mycobacterium tuberculosis|
|Supplement Type||real-time process|
|Supplement Reason|| process change: manufacturing|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for the addition of quantiferon blood collection tubes suitable for use at altitudes above 6,500 feet.