21 CFR 862.1195

§ 862.1195 Corticoids test system.

United States · 21 CFR — Food and Drugs · Status: effective

Cite this

Citation: 21 CFR 862.1195, § 862.1195 Corticoids test system, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/89079
Permanent ID: ys:prov:89079@1
SHA-256: 7880b317f63f87c3751a794cee5a743a1a8dc030432500d4c72f50415f90713a

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Full text

(a) Identification. A corticoids test system is a device intended to measure the levels of corticoids (hormones of the adrenal cortex) in serum and p lasma. 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. (b) Classification. 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.

Legislative history

This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.