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52 FR 16122, May 1, 1987, unless otherwise noted.
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Nomenclature changes to part 862 appear at 73 FR 35341, June 23, 2008.
(a) Identification. A galactose-1-phosphate uridyl transferase test system is a device intended to measure the activity of the enzyme galactose-1-phosphate uridyl transferase in erythrocytes (red blood cells). Measurements of galactose-1-phosphate uridyl transferase are used in the diagnosis and treatment of the hereditary disease galactosemia (disorder of galactose metabolism) in infants.
(b) Classification. Class II.