21 CFR § 862.1310 - Galactose test system.

---
identifier: "/us/cfr/t21/s862.1310"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 862.1310 - Galactose test system."
title_number: 21
title_name: "Food and Drugs"
section_number: "862.1310"
section_name: "Galactose test system."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "H"
subchapter_name: "MEDICAL DEVICES"
part_number: "862"
part_name: "CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 351, 360, 360c, 360e, 360j, 360 371."
regulatory_source: "52 FR 16122, May 1, 1987, unless otherwise noted."
cfr_part: "862"
---


# 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.