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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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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.
Classification Namefluroesence polorization immunoassay for cyclosporine
Generic Namefluroesence polorization immunoassay for cyclosporine
Regulation Number862.1235
Abbott Laboratories
abbott labs
abbott park, IL 60064
PMA NumberP890025
Supplement NumberS010
Date Received03/03/1997
Decision Date02/13/1998
Product Code
Advisory Committee Toxicology
Supplement Typenormal 180 day track
Supplement Reason location change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
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.