In EU: This product is CE Marked. Health Canada Licensed Lyophilized plasmas, at defined Dabigatran concentrations (2 levels of about 15-35 and 45-105 ng/mL), as measured with the HEMOCLOT Thrombin Inhibitors kit (Ref ACK002K-CAN / ACK002L-CAN), for the quality control of Dabigatran measurements with clotting or chromogenic assays.