21 CFR 862.1230 — Radioimmunoassay, Cyclic Gmp

Clinical Chemistry (CH) · Part 862 Subpart B—Clinical Chemistry Test Systems · § 862.1230

Identification

A cyclic AMP test system is a device intended to measure the level of adenosine 3′, 5′-monophosphate (cyclic AMP) in plasma, urine, and other body fluids. Cyclic AMP measurements are used in the diagnosis and treatment of endocrine disorders, including hyperparathyroidism (overactivity of the parathyroid gland). Cyclic AMP measurements may also be used in the diagnosis and treatment of Graves' disease (a disorder of the thyroid) and in the differentiation of causes of hypercalcemia (elevated levels of serum calcium.)

Classification Rationale

Class II.

Product Codes