DevicePMAs@therightstef:P890025_S010 JSONTXT

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.