§ 862.1555 Phenylalanine test system.
Current through Sep 8, 2026 · Read all of Part 862
(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.