|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|| change design/components/specifications - component|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for the institution of the use of semi-automated system for the dispensing and capping stages in the production of the positive control, panel a reagent, and panel b reagent of the t-spot. Tb test kit using the ff30 dispenser/capper from flexicon. In addition, the type of vial caps has been changed from a popcan cap to a hdpe cap which is now gamma irradiated rather than autoclaved to reduce bacterial and fungal contamination.