StacksVerified U.S. regulatory reference

21 CFR §862.1310

Verified against eCFR.gov as of June 20, 2026View official text on eCFR.gov
  1. (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.
  2. (b)Classification. Class I.