Title 21

SECTION 862.1310

862.1310 Galactose test system.

§ 862.1310 Galactose test system.

(a) Identification. A galactose test system is a device intended to measure galactose in blood and urine. Galactose measurements are used in the diagnosis and treatment of the hereditary disease galactosemia (a disorder of galactose metabolism) in infants.

(b) Classification. Class I.

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