21 CFR § 862.1025 Clinical Chemistry and Clinical Toxicology Devices

§ 862.1025 Adrenocorticotropic hormone (ACTH) test system.

Current through Sep 8, 2026 · Read all of Part 862

⚠ 2 pending changes to Part 862

(a) Identification. An adrenocorticotropic hormone (ACTH) test system is a device intended to measure adrenocorticotropic hormone in plasma and serum. ACTH measurements are used in the differential diagnosis and treatment of certain disorders of the adrenal glands such as Cushing's syndrome, adrenocortical insufficiency, and the ectopic ACTH syndrome.

(b) Classification. Class II.

← § 862.1020 Acid phosphatase (total or prostatic) test system.§ 862.1030 Alanine amino transferase (ALT/SGPT) test system. →