Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
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Device | TDX CYCLOSPORINE AND METABOLITES SERUME ASSAY |
Generic Name | Fluorescence polarization immunoassay for cyclosporine |
Regulation Number | 862.1235 |
Applicant | Abbott Laboratories ABBOTT LABS ABBOTT PARK, IL 60064 |
PMA Number | P890025 |
Supplement Number | S010 |
Date Received | 03/03/1997 |
Decision Date | 02/13/1998 |
Reclassified Date
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10/16/2002 |
Product Code |
MGU |
Advisory Committee |
Toxicology |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Location Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement Approval for change in monoclonal antibody manufacturing site from Sandoz Pharmaceuticals AG., Switzerland to Abbott Laboratories, Abbott Park, IL USA, under the trade name TDx(R)/TDxFLx(R) Cyclosporine Monoclonal Whole Blood Assay, It is indicated for the quantitative measurement of cyclosporine as an aid in the management of cardiac, liver, and renal transplant patients. |
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