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.
List of Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control devices cleared through 510(k)
How to use this database
This page lists all FDA 510(k) submissions for Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control devices (product code DAP). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.
These devices fall under the Hematology FDA review panel. Browse all Hematology devices →