CJB · Chromatographic Separation/Radioimmunoassay, Aldosterone
Clinical Chemistry · 21 CFR 862.1045 · Class 2
Overview
| Product Code | CJB |
|---|---|
| Device Name | Chromatographic Separation/Radioimmunoassay, Aldosterone |
| Regulation | 21 CFR 862.1045 |
| Device Class | Class 2 |
| Review Panel | Clinical Chemistry |
| 3rd-Party Reviewable | Yes |
Identification
An aldosterone test system is a device intended to measure the hormone aldosterone in serum and urine. Aldosterone measurements are used in the diagnosis and treatment of primary aldosteronism (a disorder caused by the excessive secretion of aldosterone by the adrenal gland), hypertension caused by primary aldosteronism, selective hypoaldosteronism, edematous states, and other conditions of electrolyte imbalance.
Classification Rationale
Class II.
Recent Cleared Devices (0 of 0)
No cleared devices on record.
