Coagulation factor IVDs

Intended purpose

An in vitro diagnostic reagent for use in assays for the quantitative determination of individual clotting factors within the coagulation cascade activity, such as FXIII , FVII, FX, FXI, etc, as aid to diagnosis and monitoring of congenital or acquired deficiencies in patients with bleeding disorders or at risk for deficiency in human sodium citrated plasma by means of automated, semi-automated and/or manual coagulometric methods.