Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling. |
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Device | EMIT 2000 CYCLOSPORINE SPECIFIC ASSAY |
Generic Name | CYCLOSPORINE |
Regulation Number | 862.1235 |
Applicant | DADE BEHRING, INC. PO BOX 6101 NEWARK, DE 19714-6101 |
PMA Number | P920031 |
Date Received | 06/29/1992 |
Decision Date | 10/02/1996 |
Reclassified Date
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10/16/2002 |
Product Code |
MKW |
Docket Number | 97M-0082 |
Notice Date | 03/21/1997 |
Advisory Committee |
Toxicology |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE EMIT(R) 2000 CYCLOSPORINE SPECIFIC ASSAY. THE DEVICE IS INDICATED FOR IN VITRO DIAGNOSTIC USE ON THE ROCHE DIAGNOSTICS SYSTEMS COBAS MIRA, COBAS MIRA S, AND COBAS MIRA PLUS CHEMISTRY SYSTEMS FOR THE QUANTITATIVE ANALYSIS OF CYCLOSPORINE (CSA) IN HUMAN WHOLE BLOOD AS AN AID IN THE MANAGEMENT OF CYCLOSPORINE THERAPY IN KIDNEY, HEART, AND LIVER TRANSPLANT PATIENTS. |
Supplements: |
S001 S002 S003 |
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