|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||COBAS INTEGRA CYCLOSPORINE|
|Applicant||DADE BEHRING, INC.|
|Supplement Type||real-time process|
|Supplement Reason|| labeling change - indications/instructions/shelf life/tradename|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval to expand the use of the cobas integra cyclosporing reagent system to the cobas integra 400 and cobas integra 800 analyzers.