|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|| Special Supplement|
|Supplement Reason|| labeling change - instructions|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for revisions to the device package insert and marketing booklet subsequent to the publication ofthe cdc's updated guidelines for using interferon gamma release assays to detect mycobacterium tuberculosis infection - united states, 2010, in accordance with the original pma post-approval requirement.