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Electronic Code of Federal Regulations

e-CFR data is current as of November 19, 2019

Title 21Chapter ISubchapter HPart 862Subpart B → §862.1315


Title 21: Food and Drugs
PART 862—CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES
Subpart B—Clinical Chemistry Test Systems


§862.1315   Galactose-1-phosphate uridyl transferase test system.

(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.

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