|Trade Name||QUANTIFERON-TB ANALYSIS SOFTWARE PROGRAM|
|Classification Name||test, immunity, cell mediated, mycobacterium tuberculosis|
|Supplement Type||real-time process|
|Supplement Reason|| change design/components/specifications - software|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for the use of the quantiferon-tb analysis software program for use with the quantiferon-tb test. The device accessory will be marketed under the trade name quantiferon-tb analysis software program and is indicated as a stand alone program for analysis of raw eia data and calculation of quantiferon-tb assay results.