21 C.F.R. · Food and Drugs
21 C.F.R. § 862.1200

Corticosterone test system.

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21 C.F.R. § 862.1200 — Corticosterone test system.

§ 862.1200 Corticosterone test system. (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. [52 FR 16122, May 1, 1987, as amended at 65 FR 2305, Jan. 14, 2000]

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21 C.F.R. § 862.1200
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The regulatory text of 21 C.F.R. § 862.1200 is reproduced from the official Code of Federal Regulations as published by the Office of the Federal Register and the National Archives and Records Administration.
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