TDXR 5-HIAA (URINE)
Device Facts
| Record ID | K854946 |
|---|---|
| Device Name | TDXR 5-HIAA (URINE) |
| Applicant | Abbott Laboratories |
| Product Code | CDA · Clinical Chemistry |
| Decision Date | Jan 17, 1986 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.1390 |
| Device Class | Class 1 |
Regulatory Classification
Identification
A 5-hydroxyindole acetic acid/serotonin test system is a device intended to measure 5-hydroxyindole acetic acid/serotonin in urine. Measurements of 5-hydroxyindole acetic acid/serotonin are used in the diagnosis and treatment of carcinoid tumors of endocrine tissue.
