AMERLEX-M CAMP(125)ASSAY SYSTEM RPA.508 (100 KIT)
Device Facts
| Record ID | K860253 |
|---|---|
| Device Name | AMERLEX-M CAMP(125)ASSAY SYSTEM RPA.508 (100 KIT) |
| Applicant | Amersham Corp. |
| Product Code | CHO · Clinical Chemistry |
| Decision Date | Mar 14, 1986 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.1230 |
| Device Class | Class 2 |
Regulatory Classification
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.)
