GASTRIN 1-17 BY RADIOIMMUNOASSAY KIT
Device Facts
| Record ID | K812727 |
|---|---|
| Device Name | GASTRIN 1-17 BY RADIOIMMUNOASSAY KIT |
| Applicant | Immuno Nuclear Corp. |
| Product Code | CGC · Clinical Chemistry |
| Decision Date | Nov 5, 1981 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.1325 |
| Device Class | Class 1 |
Regulatory Classification
Identification
A gastrin test system is a device intended to measure the hormone gastrin in plasma and serum. Measurements of gastrin are used in the diagnosis and treatment of patients with ulcers, pernicious anemia, and the Zollinger-Ellison syndrome (peptic ulcer due to a gastrin-secreting tumor of the pancreas).
