FDA 510(k)-cleared tacrolimus LC-MS/MS assay

Sept. 26, 2025

MassTrak Immunosuppressants Kit (IVD) is an FDA 510(k)-cleared LC-MS/MS assay for tacrolimus quantification in whole blood. Used with ACQUITY UPLC I-Class PLUS and Xevo TQD IVD Systems, it provides improved specificity over immunoassay methods. The kit includes chemical reagents, analytical column, calibrators, controls, and validated method instructions.

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