21 CFR 862.1205 — Radioimmunoassay, Cortisol
Clinical Chemistry (CH) · Part 862 Subpart B—Clinical Chemistry Test Systems · § 862.1205
Identification
A cortisol (hydrocortisone and hydroxycorticosterone) test system is a device intended to measure the cortisol hormones secreted by the adrenal gland in plasma and urine. Measurements of cortisol are used in the diagnosis and treatment of disorders of the adrenal gland.
Classification Rationale
Class II.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| CGR | Radioimmunoassay, Cortisol | 2 | 84 | 3rd Party |
| JFT | Fluorometric, Cortisol | 2 | 20 | 3rd Party |
| NHG | Enzyme Immunoassay, Cortisol, Salivary | 2 | 7 | 3rd Party |
