21 CFR 862.1310

§ 862.1310 Galactose test system.

United States · 21 CFR — Food and Drugs · Status: effective

Cite this

Citation: 21 CFR 862.1310, § 862.1310 Galactose test system, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/89102
Permanent ID: ys:prov:89102@1
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Full text

(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.

Legislative history

This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.