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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 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 NameTDX CYCLOSPORINE AND METABOLITES SERUME ASSAY
Classification Namefluroesence polorization immunoassay for cyclosporine
Generic Namecyclosporine and metabolites whole blood assay
Regulation Number862.1235
ApplicantABBOTT LABORATORIES
PMA NumberP890025
Supplement NumberS010
Date Received03/03/1997
Decision Date02/13/1998
Product Code
MGU
Advisory Committee Toxicology
Supplement Typenormal 180 day track
Supplement Reason location change: manufacturer
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.
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