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e-CFR data is current as of February 22, 2021 |
Title 21 → Chapter I → Subchapter H → Part 862 → Subpart B → §862.1025 |
Title 21: Food and Drugs
PART 862—CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES
Subpart B—Clinical Chemistry Test Systems
§862.1025 Adrenocorticotropic hormone (ACTH) test system.
(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.