|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 AND TB GOLD IN-TUBE|
|Classification Name||test, immunity, cell mediated, mycobacterium tuberculosis|
|Supplement Type||135 review track for 30-day notice|
|Supplement Reason|| process change: manufacturing|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for the use of the dry room at scantibodies laboratory, inc. , santee, california, to be used as an alternative method to vacuum drying in the manufacturing process of elisa plates.