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2019-nCoV Neutralization Antibody Rapid Test Cassette (Colloidal Gold Method)
EUDAMEDClass IVD General (EU MDR)
Ref CG9051-60TRef CG9051-25TRef CG9051-5TRef CG9051-40TRef CG9051-20T
Identity
- Device Name
- 2019-nCoV Neutralization Antibody Rapid Test Cassette (Colloidal Gold Method) EUDAMED
- Model / Reference
- CG9051-60T EUDAMEDCG9051-25T EUDAMEDCG9051-5T EUDAMEDCG9051-40T EUDAMEDCG9051-20T EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974323018223 EUDAMED06974323018186 EUDAMED06974323018155 EUDAMED06974323018209 EUDAMED06974323018162 EUDAMED
- Basic UDI-DI
- B-06974323018223 EUDAMEDB-06974323018186 EUDAMEDB-06974323018155 EUDAMEDB-06974323018209 EUDAMEDB-06974323018162 EUDAMED
- EMDN Code
- W0105041102 CORONAVIRUS ANTIBODIES - TOTAL 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
2019-nCoV Neutralization Antibody Rapid Test Cassette (Colloidal Gold Method) by Beijing Applied Biological Technologies Co., Ltd. — Class IVD General — IVDD…
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-06974323018223 | 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 (5)
- EUDAMED 7d5ac644-f108-4300-93dd-fe1aa23ed3cc 61 fields · synced Jul 22, 2026
- EUDAMED 3488dd6a-a0dc-4a40-9dfe-e756b91b8cc3 61 fields · synced May 18, 2026
- EUDAMED 4ff81b48-147a-46ee-847f-908206e61de6 61 fields · synced May 18, 2026
- EUDAMED a134dc5e-d772-418c-9d14-78cc6cb11f79 61 fields · synced May 19, 2026
- EUDAMED c084d9b5-188f-40e0-802f-49000ce6ec8c 61 fields · synced May 19, 2026