21 C.F.R. · Food and Drugs
21 C.F.R. § 862.1315

Galactose-1-phosphate uridyl transferase test system.

Title 21 C.F.R. ● ACTIVE Primary Source
Regulatory Text

21 C.F.R. § 862.1315 — Galactose-1-phosphate uridyl transferase test system.

§ 862.1315 Galactose-1-phosphate uridyl transferase test system. (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.

Source: ecfr.gov · govinfo.gov — public domain Official Source ↗
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21 C.F.R. § 862.1315
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The regulatory text of 21 C.F.R. § 862.1315 is reproduced from the official Code of Federal Regulations as published by the Office of the Federal Register and the National Archives and Records Administration.
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boisestandard.org United States Law CFR Title 21 21 C.F.R. § 862.1315