GastroPanel® 𝘏𝘦𝘭𝘪𝘤𝘰𝘣𝘢𝘤𝘵𝘦𝘳 𝘱𝘺𝘭𝘰𝘳𝘪
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Basic Information
- Primary DI
- 06419587060408
- Basic UDI-DI Code
- B-06419587060408
- Reference
- 606040
- Device Types
-
Single use
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd General
- Status
- On The Market
- Manufacturer
- Biohit Oyj
Additional Description
GastroPanel Helicobacter pylori test is an in vitro microplate-based quantitative enzyme-linked immunosorbent assay (ELISA) for the determination of IgG antibodies against H. pylori 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 Gastrin-17 (REF 606035). 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. GastroPanel Helicobacter pylori test is intended to be used for diagnosis of H. pylori infection in adult patients.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W01021499 | MULTIPLE IMMUNOCHEMISTRY REAGENTS - OTHER |
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