|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|
|Classification Name||test, immunity, cell mediated, mycobacterium tuberculosis|
|Supplement Type||30-day notice|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Change to the manufacturing process of the quantiferon-tb to allow the use of k-blue max substrate as an alternative substrate reagent to increase the shelf life of the kit to 3 years.