Regulations last checked for updates: Feb 06, 2026

Title 21 - Food and Drugs last revised: Dec 18, 2026
§ 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.

authority: 21 U.S.C. 351,360,360c,360e,360j,360
source: 52 FR 16122, May 1, 1987, unless otherwise noted.
cite as: 21 CFR 862.1377