Basic Information
- Primary DI
- 06419587606088
- Basic UDI-DI Code
- B-06419587606088
- Reference
- 606080
- Device Types
-
Single use
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd General
- Status
- On The Market
- Manufacturer
- Biohit Oyj
Additional Description
GastroPanel Four-in-One test is an in vitro microplate-based quantitative enzyme-linked immunosorbent assay (ELISA) for the detection of pepsinogen I (PGI), pepsinogen II (PGII), gastrin-17 (G-17) and IgG antibodies against Helicobacter pylori (Hp) from human EDTA plasma samples. The dedicated software GastroSoft can be used for result interpretation and reporting of all four assays of GastroPanel Four-in-One. Test can be conducted either manually or automatically by the healthcare professionals. GastroPanel Four-in-One 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, the test aids in screening conditions that necessitate additional examination or treatment from healthy stomach mucosa.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W01021499 | MULTIPLE IMMUNOCHEMISTRY REAGENTS - OTHER |
Similar Devices
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