FDA Product Code DAP: Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control

Under FDA product code DAP, fibrinogen and fibrin split product antigen/antibody detection systems are cleared for the evaluation of coagulation disorders.

These tests measure fibrin degradation products and D-dimer in plasma to detect excessive fibrinolysis, disseminated intravascular coagulation, and venous thromboembolism. Elevated FDP and D-dimer indicate ongoing coagulation and fibrinolysis activity.

DAP devices are Class II medical devices, regulated under 21 CFR 864.7320 and reviewed by the FDA Hematology panel.

Leading manufacturers include Instrumentation Laboratory CO, Dade Behring, Inc. and Organon Teknika Corp..