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Code · CFR · Title 21 — Food and Drugs · Part 862 — Clinical Chemistry and Clinical Toxicology Devices · § 862.1310

§ 862.1310. Galactose test system.

42 words·~1 min read·/us/cfr/t21/s§ 862.1310·

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(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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