FDA Product Code CDZ: Radioimmunoassay, Testosterones And Dihydrotestosterone

FDA product code CDZ covers radioimmunoassay systems for the measurement of testosterone and dihydrotestosterone in serum.

These assays quantify androgens involved in male sexual development, reproductive function, and secondary sex characteristics. Testosterone measurement is used in the diagnosis of hypogonadism, polycystic ovary syndrome, and monitoring of androgen replacement therapy.

CDZ devices are Class I medical devices, regulated under 21 CFR 862.1680 and reviewed by the FDA Immunology panel.

Leading manufacturers include Diagnostic Products Corp., Diagnostic Systems Laboratories, Inc. and Beckman Coulter, Inc..