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SARS-CoV-2 Neutralization Antibody Rapid Test Cassette (FIA)
EUDAMEDClass IVD General (EU MDR)
Ref CF6011
Identity
- Device Name
- SARS-CoV-2 Neutralization Antibody Rapid Test Cassette (FIA) EUDAMED
- Model / Reference
- CF6011 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974323014027 EUDAMED06974323014058 EUDAMED06974323014003 EUDAMED06974323014034 EUDAMED
- Basic UDI-DI
- B-06974323014027 EUDAMEDB-06974323014058 EUDAMEDB-06974323014003 EUDAMEDB-06974323014034 EUDAMED
- EMDN Code
- W0105041199 OTHER CORONAVIRUS REAGENTS 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
SARS-CoV-2 Neutralization Antibody Rapid Test Cassette (FIA) by Beijing Applied Biological Technologies 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-06974323014027 | 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 (4)
- EUDAMED 3ad4a0b2-6237-4e64-a815-a27da972bd4d 61 fields · synced Jul 29, 2026
- EUDAMED c7a7692b-e01a-435c-bdd6-dad411a15f5f 61 fields · synced May 17, 2026
- EUDAMED 3a8dc36c-82d5-4085-bcb6-c162f3b7d44c 61 fields · synced May 19, 2026
- EUDAMED 0baf030c-acd9-4c39-a874-12b75d826a46 61 fields · synced May 19, 2026