21 CFR 862.1285
§ 862.1285 Etiocholanolone test system.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 862.1285, § 862.1285 Etiocholanolone test system, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/89097
- Permanent ID
ys:prov:89097@1- SHA-256
cc0ca53e399cbcf4124223c21ef84087b26461154bb25d95cbbd025976bcdfe6
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Full text
(a) Identification. An etiocholanolone test system is a device intended to measure etiocholanolone in serum and urine. Etiocholanolone is a metabolic product of the hormone testosterone and is excreted in the urine. Etiocholanolone measurements are used in the diagnosis and treatment of disorders of the testes and ovaries.
(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.