QUANTASE PHENYLALANINE ASSAY
Device Facts
| Record ID | K961515 |
|---|---|
| Device Name | QUANTASE PHENYLALANINE ASSAY |
| Applicant | Shield Diagnostics, Ltd. |
| Product Code | JNB · Clinical Chemistry |
| Decision Date | Jun 12, 1996 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.1555 |
| Device Class | Class 2 |
Regulatory Classification
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.
