21 CFR 862.1377
§ 862.1377 Urinary homocystine (nonquantitative) test system.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 862.1377, § 862.1377 Urinary homocystine (nonquantitative) test system, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/89119
- Permanent ID
ys:prov:89119@1- SHA-256
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Full text
(a) Identification. A urinary homocystine (nonquantitative) test system is a device intended to identify homocystine (an analogue of the amino acid cystine) in urine. The identification of urinary homocystine is used in the diagnosis and treatment of homocystinuria (homosystine in urine), a heritable metabolic disorder which may cause mental retardation.
(b) Classification. Class II.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.