Basic Information
- Primary DI
- 06419587602332
- Basic UDI-DI Code
- B-06419587602332
- Reference
- 602330
- Device Types
- None provided
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd General
- Status
- No Longer On The Market
- Manufacturer
- Biohit Oyj
Additional Description
GP Reader is a bench top instrument for the quantitative measurement of fluorescence signals from multichannel lateral flow cassettes. GP Reader with software including interpretation algorithm is intended to be used in conjunction with GastroPanel quick test (REF 602320) for diagnosing Helicobacter pylori infection and atrophic gastritis (AG) from patients with dyspeptic symptoms or at risk to develop malignant cellular changes in stomach mucosa. In addition, with GastroPanel quick test, GP Reader aids in screening conditions that necessitate additional examination or treatment from healthy stomach mucosa. GP Reader 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 |
|---|---|
| W0201069099 | VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER |
Similar Devices
Other on-the-market devices with the same classification (Eu Ivd General) and regulation (EU IVDD).