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21 CFR 862.1555

§ 862.1555 Phenylalanine test system.

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

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21 CFR 862.1555, § 862.1555 Phenylalanine test system, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/89157
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(a) Identification. A phenylalanine test system is a device intended to measure free phenylalanine (an amino acid) in serum, plasma, and urine. Measurements of phenylalanine are used in the diagnosis and treatment of congenital phenylketonuria which, if untreated, may cause mental retardation. (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.