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Basic Information
- Primary DI
- 06419587064000
- Basic UDI-DI Code
- B-06419587064000
- Reference
- 606400
- Device Types
-
Single use
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd General
- Status
- On The Market
- Manufacturer
- Biohit Oyj
Additional Description
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. The test can be conducted either manually or automatically and is to be used by healthcare professionals. For in vitro diagnostic use.
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).