Helicobacter ViraChip IgG Positive Control
by Viramed Biotech AG EUDAMED
Active
Ref V-HPCGPKModel Helicobacter Control
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | Number++EVIRHelicobacterContrLU | Date15 Sep 2026 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/IVDR Active
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Specification
- Device Name
- Helicobacter ViraChip IgA Positive Control
- Model / Reference
- Helicobacter Control, V-HPCGPK
- Primary DI / UDI-DI
- EVIRHPCGPK1
- Basic UDI-DI
- ++EVIRHelicobacterContrLU
- Direct Marketing DI
- EVIRHPCGPK1
- EMDN Code
- W0105010402 H. pylori antibody assays
- Device Class
- Class B
- Market of Registration
- Germany
Manufacturer details
- EUDAMED SRN
- DE-MF-000020368
Other devices from Viramed Biotech AG
Properties
Other properties (7)
- Sterile: No
- Human Tissues: No
- Self Testing: No
- Near-Patient Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No
- New Device: No