510(k) Cleared for In Vitro Diagnostic Use.

Abnormal human plasma for the quality control of assays for Protein C, Protein S, Antithrombin, PT, aPTT, Fibrinogen, Factor VIII:C, Prothrombin, Factors VII+X, Factors V, VII, IX, X, XI, XII, Plasminogen, α2-Antiplasmin, PT/INR/%, aPTT, and vWF:Ag. The exact concentration and the acceptance ranges for each factor are indicated on the flyer provided with each kit. May also be used as negative control for Lupus Anticoagulant.