Regulations last checked for updates: Oct 17, 2024

Title 21 - Food and Drugs last revised: Oct 15, 2024
§ 862.1140 - Calcitonin test system.

(a) Identification. A calcitonin test system is a device intended to measure the thyroid hormone calcitonin (thyrocalcitonin) levels in plasma and serum. Calcitonin measurements are used in the diagnosis and treatment of diseases involving the thyroid and parathyroid glands, including carcinoma and hyperparathyroidism (excessive activity of the parathyroid gland).

(b) Classification. Class II.

authority: 21 U.S.C. 351,360,360c,360e,360j,360l,371
source: 52 FR 16122, May 1, 1987, unless otherwise noted.
cite as: 21 CFR 862.1140