URINARY FREE CATECHOLAMINES & METANEPHRINES (HPLC)
Device Facts
| Record ID | K873371 |
|---|---|
| Device Name | URINARY FREE CATECHOLAMINES & METANEPHRINES (HPLC) |
| Applicant | Bio-Rad |
| Product Code | CHQ · Clinical Chemistry |
| Decision Date | Jan 5, 1988 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.1165 |
| Device Class | Class 1 |
Regulatory Classification
Identification
A catecholamines (total) test system is a device intended to determine whether a group of similar compounds (epinephrine, norepinephrine, and dopamine) are present in urine and plasma. Catecholamine determinations are used in the diagnosis and treatment of adrenal medulla and hypertensive disorders, and for catecholamine-secreting tumors (pheochromo-cytoma, neuroblastoma, ganglioneuroma, and retinoblastoma).
