The ConcizuTrace™ ELISA device is for use in determining the concentration of the drug, concizumab, in 3.2% citrated plasma from patients with Haemophilia A & B, with and without inhibitors, who are undergoing treatment with concizumab for routine prophylaxis of bleeding episodes. The device is a sandwich ELISA. The intended users are trained laboratory professionals.
A collection of reagents and other associated materials intended to be used for the quantitative measurement and therapeutic monitoring of the therapeutic antibody concizumab, an anti-tissue factor pathway inhibitor (TFPI), in a clinical specimen, using an enzyme immunoassay (EIA) method.
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