21 CFR 862.1200
§ 862.1200 Corticosterone test system.
United States · 21 CFR — Food and Drugs · Status: effective
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- Citation
- 21 CFR 862.1200, § 862.1200 Corticosterone test system, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/89080
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Full text
(a) Identification. A corticosterone test system is a device intended to measure corticosterone (a steroid secreted by the adrenal gland) levels in plasma. Measurements of corticosterone are used in the diagnosis and treatment of adrenal disorders such as adrenal cortex disorders and blocks in cortisol synthesis.
(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.