|Trade Name||QUANTIFERON - 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 to allow the use of dry peptides to be formulated at cellestis and shipped to the contract manufacturer for the manufacture of tb antigen blood collection tubes.