21 CFR § 862.1140 Clinical Chemistry and Clinical Toxicology Devices

§ 862.1140 Calcitonin test system.

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

⚠ 2 pending changes to Part 862

(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.

← § 862.1135 C-peptides of proinsulin test system.§ 862.1145 Calcium test system. →