21 CFR 862.1075
§ 862.1075 Androstenedione test system.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 862.1075, § 862.1075 Androstenedione test system, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/89048
- Permanent ID
ys:prov:89048@1- SHA-256
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Full text
(a) Identification. An androstenedione test system is a device intended to measure androstenedione (a substance secreted by the testes, ovary, and adrenal glands) in serum. Adrostenedione measurements are used in the diagnosis and treatment of females with excessive levels of androgen (male sex hormone) production.
(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.