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Title 21 Part 862 → Subpart B → §862.1310

Title 21 → Chapter I → Subchapter H → Part 862 → Subpart B → §862.1310

Electronic Code of Federal Regulations e-CFR

Title 21 Part 862 → Subpart B → §862.1310

e-CFR data is current as of January 27, 2020

Title 21Chapter ISubchapter HPart 862Subpart B → §862.1310


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


§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.