|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||T-SPOT .TB TEST|
|Classification Name||mycobacterium tuberculosis, cell mediated immune response, enzyme-linked immunospot test|
|Supplement Type||real-time process|
|Supplement Reason|| design change - minor|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for a design change, for a larger reagent volume format for the t-cell xtend reagent, an accessory to the t-spot tb test, to increase the volume from 3 x 2ml vials in a pack to a 50ml bottle.