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QIAstat-Dx BCID GPF Plus AMR Panel
EUDAMEDClass C (EU MDR)
Ref 691812
by QIAGEN GmbH
Identity
- Trade Name
- QIAstat-Dx BCID GPF Plus AMR Panel EUDAMED
- Device Name
- QIAstat-Dx BCID GPF Plus AMR Panel EUDAMED
- Model / Reference
- 691812 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04053228049395 EUDAMED
- Basic UDI-DI
- 4053228RBCIDGPFQST00001AM EUDAMED
- Direct Marketing DI
- 04053228049395 EUDAMED
- EMDN Code
- W0105070201 GRAM+ - GRAM- - FUNGI - MULTIPLEX NA REAGENTS 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
Yes
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
Yes
EUDAMED
QIAstat-Dx BCID GPF Plus AMR Panel 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 | 4053228RBCIDGPFQST00001AM | Class C | Active |
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Manufacturer
- Manufacturer
- QIAGEN GmbH
- EUDAMED SRN
- DE-MF-000004949
Sources (1)
- EUDAMED 126158ef-9311-46e1-8535-faa648cab78f 61 fields · synced Jul 11, 2026