21 C.F.R. § 862.1377

Urinary homocystine (nonquantitative) test system.

Last amended: 2016Year: 2026Length: 54 wordsSubsections: 1Official source

Cite as 21 C.F.R. § 862.1377 (2026)

(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.
21 C.F.R. § 862.1377: Urinary homocystine (nonquantitative) test system. | Justis AI