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 Beckman Coulter, Inc. and Immunodiagnostic Systems , Ltd..
List of Radioimmunoassay, Cortisol devices cleared through 510(k)
How to use this database
This page lists all FDA 510(k) submissions for Radioimmunoassay, Cortisol devices (product code CGR). 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 →