21 CFR Part 862 · Clinical Chemistry and Clinical Toxicology Devices

§ 862.1230 Cyclic AMP test system

Subpart B - Clinical Chemistry Test Systems Official text on eCFR Amendment history

(a) 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.)

(b) Classification. Class II.

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Amendment history

Federal Register documents that created or amended this section.