K Number
K000754Device Name
QUANTASE PHENYLALANINE SCREENING ASSAY 500 TEST KIT
Manufacturer
Date Cleared
2000-06-19
(103 days)
Product Code
Regulation Number
862.1555AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
More Information
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§ 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.
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