In US: 510(k) Cleared for In Vitro Diagnostic Use for Plasma only. Enzyme immuno-assay designed for measuring globally all heparin-dependent antibodies, whether the isotype is: IgG, IgM and IgA, in human plasma. This assay is proposed as screening, as an early identification of heparin treated patients presenting a risk to develop HIT or HITT. This assay measures the whole of antibodies. It offers the highest sensitivity as all isotypes are detected. It is the preferred assay when an early detection of heparin dependent antibodies is required for assessing the development risk of HIT/HITT.