Identity
- Trade Name
- QFT-Plus 2 Plate Kit ELISA EUDAMED
- Device Name
- QuantiFERON-TB Gold Plus (QFT-Plus) EUDAMED
- Model / Reference
- 622120 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04053228022107 EUDAMED
- Basic UDI-DI
- 4053228RTBQFT0000000001W8 EUDAMED
- EMDN Code
- W0105010704 TB-IGRA (INTERFERON-GAMMA-RELEASE ASSAY) EUDAMED
Classification
- Device Class
- Class C EUDAMED
- Market of Registration
- Austria EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
QFT-Plus 2 Plate Kit ELISA by QIAGEN GmbH — Class C — IVDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 4053228RTBQFT0000000001W8 | Class C | Active |
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Manufacturer
- Manufacturer
- QIAGEN GmbH
- EUDAMED SRN
- DE-MF-000004949
Sources (1)
- EUDAMED b93f1826-dce9-40bb-ab26-818ce90478ac 61 fields · synced Jun 19, 2026