Basic Information
- Primary DI
- 06419587740195
- Basic UDI-DI Code
- B-06419587740195
- Reference
- 740193
- Device Types
- None provided
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd General
- Status
- On The Market
- Manufacturer
- Biohit Oyj
Additional Description
GastroSoft is a software application intended to be used for result interpretation and reporting of four GastroPanel biomarkers (pepsinogen I, pepsinogen II, gastrin-17, and Helicobacter pylori antibodies) with optional anamnestic information. GastroSoft aids in diagnosis of H. pylori infection and atrophic gastritis (AG) from patients with dyspeptic symptoms or at risk to develop malignant cellular changes in stomach mucosa. GastroSoft can aid in screening conditions that necessitate additional examination or treatment from healthy stomach mucosa. The software application is to be used by healthcare professionals, either in a laboratory-based or point of care (POC) setting. For in vitro diagnostic use.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0201020292 | LIMITED PANEL IMMUNOCHEMISTRY ANALYSERS - IVD MEDICAL DEVICE SOFTWAE |
Similar Devices
Other on-the-market devices with the same classification (Eu Ivd General) and regulation (EU IVDD).