In US: 510(k) Cleared for In Vitro Diagnostic Use.

Range of calibration plasmas supplemented with Low Molecular Weight Heparin (LMWH) (4 sets at 5 different heparin levels from 0 to 1.60 IU/mL) for the assay of heparin (UFH or LMWH) using chromogenic anti-Xa assays.