|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.|
|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 labeling changes to the instructions for use that enhance the safe use of the quantiferon-tb by incorporating recommendations from the "cdc guidelines for using the quantiferon-tb test for diagnosing latent mycobacterium tuberculosis infection" (mmwr dispatch, vol. 51/december 18, 2002).