|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||30-day notice|
|Supplement Reason|| process change: manufacturing|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Addition of an extra approved supplier (us biological, inc. ) of phytohemagglutinin and of another supplier (thermo fisher scientific gmbh) of antigen peptides (panels a and b) for the t-spot®. Tb kits.