In EU: This Product is CE Marked. Health Canada Licensed. Chromogenic assay for the measurement of Factor IX activity in human citrated plasma or Factor IX concentrates. Automated or Manual Method. Calibrator plasma and controls (at two levels) are available. This assay offers two working ranges for Factor IX (Low: 0 to 20% and High: 5 to 200%). For purified Factor IX or concentrates, a pre-dilution in Factor IX deficient plasma is recommended. Replaces product code A221805.