|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||ABBOTT IMX TACROLIMUS II|
|Classification Name||enzyme immunoassay, tracrolimus|
|Supplement Type||real-time process|
|Supplement Reason|| labeling change - instructions|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for adding "caution: this product contains natural dry rubber" to the labeling.