DDF — Prothrombin, Antigen, Antiserum, Control Class I

FDA Device Classification

FDA product code DDF covers "Prothrombin, Antigen, Antiserum, Control", a Class I medical device regulated under 21 CFR 866.5735. Submissions are reviewed by the Immunology panel. At least 2 recent 510(k) clearances have been granted under this product code.