21 C.F.R. § 862.1555

Current through September 30, 2024
Section 862.1555 - Phenylalanine test system
(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.

21 C.F.R. § 862.1555