21 CFR 862.1195 — Radioimmunoassay, Corticoids
Clinical Chemistry (CH) · Part 862 Subpart B—Clinical Chemistry Test Systems · § 862.1195
Identification
A corticoids test system is a device intended to measure the levels of corticoids (hormones of the adrenal cortex) in serum and plasma. Measurements of corticoids are used in the diagnosis and treatment of disorders of the cortex of the adrenal glands, especially those associated with hypertension and electrolyte disturbances.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| CHE | Radioimmunoassay, Corticoids | 1 | 0 |
