Basic Information
- Primary DI
- 06419587060354
- Basic UDI-DI Code
- B-06419587060354
- Reference
- 606035
- Device Types
-
Single use
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd General
- Status
- On The Market
- Manufacturer
- Biohit Oyj
Additional Description
GastroPanel Gastrin (G-17) test is an in vitro microplate-based quantitative enzyme-linked immunosorbent assay (ELISA) for the determination of human gastrin-17 from EDTA plasma samples and is intended to be used in conjunction with the other tests of GastroPanel Unified (REF 606400): GastroPanel Pepsinogen I (REF 606010), GastroPanel Pepsinogen II (REF 606020) and GastroPanel Helicobacter pylori (REF 606040). The dedicated software GastroSoft can be used for result interpretation and reporting of all four tests of GastroPanel Unified. Test can be conducted either manually or automatically by the healthcare professionals. GastroPanel Unified test is intended for diagnosing H. pylori infection and atrophic gastritis (AG) from patients with dyspeptic symptoms or at risk to develop malignant cellular changes in stomach mucosa. In addition, GastroPanel Unified test aids in screening conditions that necessitate additional examination or treatment from healthy stomach mucosa as well as GastroPanel Gastrin-17 test. G-17 is a direct biomarker of antral structure and function, and an indirect biomarker of gastric corpus. Furthermore, GastroPanel Gastrin-17 test is intended for screening and monitoring the acid output of the stomach.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W01021499 | MULTIPLE IMMUNOCHEMISTRY REAGENTS - OTHER |
Similar Devices
Other on-the-market devices with the same classification (Eu Ivd General) and regulation (EU IVDD).