PMA P890025S010
- Device
- Tdx Cyclosporine And Metabolites Serume Assay
- Applicant
- Abbott Laboratories
- PMA number
- P890025
- Supplement
- S010
- Decision date
- 1998-02-13
Current openFDA PMA Record
- Device
- TDX CYCLOSPORINE AND METABOLITES SERUME ASSAY
- Applicant
- Abbott Laboratories
- PMA number
- P890025
- Supplement
- S010
- Product code
- MGU
- Generic name
- Fluorescence polarization immunoassay for cyclosporine
- Decision date
- 1998-02-13
- Decision code
- APPR
- Date received
- 1997-03-03
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- 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.