Eu Ivdd
Eu Ivd General
On The Market
🇩🇪 Germany
H. PYLORI ANTIBODY ASSAYS
Devices (same UDI-DI)
1
Certificates
1
Countries
0
Notified Bodies
1
Basic Information
- Primary DI
- D-ILE-HEL036B
- Basic UDI-DI Code
- B-ILE-HEL036B
- Reference
- ILE-HEL03
- Device Types
-
Single use
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd General
- Status
- On The Market
- Manufacturer
- Gold Standard Diagnostics Kassel GmbH
Additional Description
Helicobacter IgM ELISAs are Enzyme Immunoassays based on Microtiter Plates which are intended for the detection and the quantitative determination of human IgM antibodies directed towards Helicobacter pylori antigens in serum and plasma. The tests are designed for in vitro diagnostic use only. They are intended for manual performance by trained professional users.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0105010402 | H. PYLORI ANTIBODY ASSAYS |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| IVDD Annex IV (excluding sections 4, 6) | SX 1701347-1 | TÜV Rheinland LGA Products GmbH |
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