JNC · Column Or Paper Chromatography Plus Ninhydrin, Phenylalanine
Clinical Chemistry · 21 CFR 862.1555 · Class 2
Overview
| Product Code | JNC |
|---|---|
| Device Name | Column Or Paper Chromatography Plus Ninhydrin, Phenylalanine |
| Regulation | 21 CFR 862.1555 |
| Device Class | Class 2 |
| Review Panel | Clinical Chemistry |
| 3rd-Party Reviewable | Yes |
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.
Classification Rationale
Class II.
Cleared Devices (0)
No cleared devices on record.
