Title 21

SECTION 862.1377

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.

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