|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 KIT|
|Classification Name||test, immunity, cell mediated, mycobacterium tuberculosis|
|Supplement Type||30-day notice|
|Supplement Reason|| process change: manufacturing|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Change the supplier for phytohaemagglu-tinin (pha-p), which is used to formulate the mitogen component in the quantiferon-tb kit.