Regulatory Text
21 C.F.R. § 862.1377 — Urinary homocystine (nonquantitative) test system.
§ 862.1377 Urinary homocystine (nonquantitative) test system. (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.
Source: ecfr.gov · govinfo.gov — public domain
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21 C.F.R. § 862.1377
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The regulatory text of 21 C.F.R. § 862.1377 is reproduced from the official Code of Federal Regulations as published by the Office of the Federal Register and the National Archives and Records Administration.
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