Basic Information
- Primary DI
- 06419587602417
- Basic UDI-DI Code
- B-06419587602417
- Reference
- 602410
- Device Types
-
Single use
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd General
- Status
- On The Market
- Manufacturer
- Biohit Oyj
Additional Description
GastroPanel quick test NT (REFs 602410, 602420) is an in vitro semi automated immunological lateral flow test for the quantitative detection of pepsinogen I (PGI), pepsinogen II (PGII), gastrin-17 (G-17), and qualitative detection of antibodies against Helicobacter pylori (Hp), from human EDTA-plasma, and venous whole blood (REF 602410), or finger prick whole blood samples (REF 602420). GastroPanel quick test NT is used with the GP Reader NT device (REF 740450), and the embedded interpretation software. The test is to be used by healthcare professionals, either in a laboratory-based or point of care (POC) setting. GastroPanel quick test NT 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 can aid in screening conditions that necessitate additional examination or treatment from healthy stomach mucosa.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W01021699 | RAPID TESTS & POINT OF CARE - IMMUNOCHEMISTRY - OTHER |
Similar Devices
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