Eu Ivdd
Eu Ivd General
On The Market
๐ซ๐ฎ Finland
๐๐ฆ๐ญ๐ช๐ค๐ฐ๐ฃ๐ข๐ค๐ต๐ฆ๐ณ ๐ฑ๐บ๐ญ๐ฐ๐ณ๐ช IgG
Devices (same UDI-DI)
1
Certificates
0
Countries
0
Notified Bodies
0
Basic Information
- Primary DI
- 06419587010403
- Basic UDI-DI Code
- B-06419587010403
- Reference
- 601040.02
- Device Types
-
Single use
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd General
- Status
- On The Market
- Manufacturer
- Biohit Oyj
Additional Description
Helicobacter pylori IgG test is an in vitro microplate-based qualitative enzyme-linked immunosorbent assay (ELISA) for the determination of IgG antibodies against Helicobacter pylori from EDTA plasma or serum samples. The test is intended for diagnosis of H. pylori infection in adult patients. The test can be conducted either manually or automatically and is to be used by healthcare professionals.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0105010402 | H. PYLORI ANTIBODY ASSAYS |
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