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Influenza A & B Ag Rapid Test Strip (Swab)
EUDAMEDClass IVD General (EU MDR)
Ref GCFLU(A/B)-501a
Identity
- Trade Name
- Influenza A & B Ag Rapid Test Strip (Swab) EUDAMED
- Device Name
- Influenza A & B Ag Rapid Test Strip (Swab) EUDAMED
- Model / Reference
- GCFLU(A/B)-501a EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-GCFLU(A/B)-501aAB EUDAMED
- Basic UDI-DI
- B-GCFLU(A/B)-501aAB EUDAMED
- EMDN Code
- W0105099004 INFLUENZA A AND /OR B - RT & POC EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Germany 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
Influenza A & B Ag Rapid Test Strip (Swab) by Zhejiang Orient Gene Biotech Co., Ltd — Class IVD General — IVDD — listed in EUDAMED
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-GCFLU(A/B)-501aAB | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Zhejiang Orient Gene Biotech Co., Ltd
- EUDAMED SRN
- CN-MF-000017965
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED ade23c84-0037-4485-a66d-04625abbcc7e 61 fields · synced Jun 18, 2026