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Electronic Code of Federal Regulations

e-CFR data is current as of October 16, 2019

Title 21Chapter ISubchapter HPart 862Subpart 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.

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