Basic Information
- Primary DI
- 06419587010359
- Basic UDI-DI Code
- B-06419587010359
- Reference
- 601035
- Device Types
-
Single use
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd General
- Status
- On The Market
- Manufacturer
- Biohit Oyj
Additional Description
Gastrin-17 Advanced test is an in vitro microplate-based quantitative enzyme-linked immunosorbent assay (ELISA) for the determination of human gastrin-17 (G-17) from EDTA plasma or serum samples. The test is intended to aid in diagnosing atrophic gastritis (AG) from patients with Helicobacter pylori infection or at risk to develop malignant cellular changes in stomach mucosa. In addition, the test aids in screening conditions that necessitate additional examination or treatment from healthy stomach mucosa as G-17 is a direct biomarker of antral structure and function, and an indirect biomarker of gastric corpus. Furthermore, Gastrin-17 Advanced test is intended for screening and monitoring the acid output of the stomach. The test can be conducted either manually or automatically and is to be used by healthcare professionals.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0102019099 | SPECIFIC PROTEINS - OTHER |
Similar Devices
Other on-the-market devices with the same classification (Eu Ivd General) and regulation (EU IVDD).