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Zika Virus NS1 Antigen Rapid Test Cassette (Colloidal Gold Method)
EUDAMEDClass IVD General (EU MDR)
Ref IH020
Identity
- Device Name
- Zika Virus NS1 Antigen Rapid Test Cassette (Colloidal Gold Method) EUDAMED
- Model / Reference
- IH020 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974323018728 EUDAMED
- Basic UDI-DI
- B-06974323018728 EUDAMED
- EMDN Code
- W0105040630 ZIKA VIRUS EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
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
Zika Virus NS1 Antigen Rapid Test Cassette (Colloidal Gold Method) by Beijing Applied Biological Technologies Co., Ltd. — Class IVD General — IVDD — listed in…
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-06974323018728 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Beijing Applied Biological Technologies Co., Ltd.
- EUDAMED SRN
- CN-MF-000012338
- Authorised Representative
- Luxus Lebenswelt GmbH DE-AR-000005110
Sources (1)
- EUDAMED e8f9564e-4127-43c8-9d00-067c57d721cf 61 fields · synced Jun 18, 2026