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 Beckman Coulter, Inc. and Roche Diagnostics.
List of Radioimmunoassay, Testosterones And Dihydrotestosterone devices cleared through 510(k)
How to use this database
This page lists all FDA 510(k) submissions for Radioimmunoassay, Testosterones And Dihydrotestosterone devices (product code CDZ). 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 Chemistry FDA review panel. Browse all Chemistry devices →