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Code · CFR · Title 21 — Food and Drugs · Part 862 — Clinical Chemistry and Clinical Toxicology Devices · § 862.1555

§ 862.1555. Phenylalanine test system.

46 words·~1 min read·/us/cfr/t21/s§ 862.1555·

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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.
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