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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
- 06974323018735 EUDAMED
- Basic UDI-DI
- B-06974323018735 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-06974323018735 | 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 e6098ea3-6e04-45a5-ab79-37159eb6ca2d 61 fields · synced Jul 11, 2026