CGT · Radioimmunoassay, Cyclic Gmp
Clinical Chemistry · 21 CFR 862.1230 · Class 2
Overview
| Product Code | CGT |
|---|---|
| Device Name | Radioimmunoassay, Cyclic Gmp |
| Regulation | 21 CFR 862.1230 |
| Device Class | Class 2 |
| Review Panel | Clinical Chemistry |
| 3rd-Party Reviewable | Yes |
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.
Recent Cleared Devices (0 of 0)
No cleared devices on record.
