21 CFR 862.1300
§ 862.1300 Follicle-stimulating hormone test system.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 862.1300, § 862.1300 Follicle-stimulating hormone test system, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/89100
- Permanent ID
ys:prov:89100@1- SHA-256
f2da997fe3a3f771e85011b030b81ccec12bfc0256ed19c138e6385a0cb6b094
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Full text
(a) Identification. A follicle-stimulating hormone test system is a device intended to measure follicle-stimulating hormone (FSH) in plasma, serum, and urine. FSH measurements are used in the diagnosis and treatment of pituitary gland and gonadal disorders.
(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.