FDA Product Code CGR: Radioimmunoassay, Cortisol

Under FDA product code CGR, radioimmunoassay systems for cortisol measurement are cleared for the evaluation of adrenal function.

These assays measure cortisol levels in serum, plasma, urine, or saliva for the diagnosis of Cushing's syndrome, adrenal insufficiency, and congenital adrenal hyperplasia, and for monitoring steroid replacement therapy.

CGR devices are Class II medical devices, regulated under 21 CFR 862.1205 and reviewed by the FDA Chemistry panel.

Leading manufacturers include Diagnostic Products Corp., Beckman Coulter, Inc. and Corning Medical & Scientific.