21 CFR 862.1140 — Radioimmunoassay, Calcitonin

Clinical Chemistry (CH) · Part 862 Subpart B—Clinical Chemistry Test Systems · § 862.1140

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).

Classification Rationale

Class II.

Product Codes

Product CodeDevice NameClassDevicesAttributes
JKRRadioimmunoassay, Calcitonin2203rd Party
Innolitics

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