21 CFR 862.1245
§ 862.1245 Dehydroepiandrosterone (free and sulfate) test system.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 862.1245, § 862.1245 Dehydroepiandrosterone (free and sulfate) test system, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/89089
- Permanent ID
ys:prov:89089@1- SHA-256
6052bc381eaea00221f091f9e2a1951361a2d4e133e719f8793426f589faf522
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Full text
(a) Identification. A dehydroepiandrosterone (free and sulfate) test system is a device intended to measure dehydroepiandrosterone (DHEA) and its sulfate in urine, serum, plasma, and amniotic fluid. Dehydroepiandrosterone measurements are used in the diagnosis and treatment of DHEA-secreting adrenal carcinomas.
(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.