Eu Ivdd
Eu Ivd Self Testing
On The Market
🇫🇮 Finland
Biocard™ H pylori IgG Home
Devices (same UDI-DI)
1
Certificates
1
Countries
0
Notified Bodies
1
Basic Information
- Primary DI
- 06416842918030
- Basic UDI-DI Code
- B-06416842918030
- Reference
- 3-018-200
- Device Types
-
Single use Sterile
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd Self Testing
- Status
- On The Market
- Manufacturer
- Labsystems Diagnostics Oy
Additional Description
Biocard™ Helicobacter pylori IgG is a home test for the detection of Helicobacter pylori antibodies from a fingertip blood sample.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0105010402 | H. PYLORI ANTIBODY ASSAYS |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| IVDD Annex III Section 6 | C-02-1172-804-22 | Eurofins Electric & Electronics Finland Oy | Expired |
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