21 CFR 862.1315
§ 862.1315 Galactose-1-phosphate uridyl transferase test system.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 862.1315, § 862.1315 Galactose-1-phosphate uridyl transferase test system, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/89103
- Permanent ID
ys:prov:89103@1- SHA-256
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Full text
(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.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.