|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 400 PLUS CYCLOSPORINE|
|Applicant||DADE BEHRING, INC.|
|Supplement Type||normal 180 day track|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for expanding the use of the cobas integra cyclosporine reagent to the cobas integra 400 plus analyzer. The device, as modified, will be marketed under the trade name cobas integra cyclosporine and is indicated for quantitative determination of cyclosporine in whole blood as an aid in the management of cyclosporine therapy in kidney, heart and liver transplant patients.