← Back to catalogue
SARS-CoV-2 Neutralization Antibody Rapid Test Cassette (Lateral Flow Method)
EUDAMEDClass IVD General (EU MDR)
Ref CG9081
Identity
- Device Name
- SARS-CoV-2 Neutralization Antibody Rapid Test Cassette (Lateral Flow Method) EUDAMED
- Model / Reference
- CG9081 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974323019633 EUDAMED06974323019640 EUDAMED06974323019657 EUDAMED06974323019626 EUDAMED06974323019664 EUDAMED
- Basic UDI-DI
- B-06974323019633 EUDAMEDB-06974323019640 EUDAMEDB-06974323019657 EUDAMEDB-06974323019626 EUDAMEDB-06974323019664 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 (Lateral Flow 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-06974323019633 | Class IVD General | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Beijing Applied Biological Technologies Co., Ltd.
- EUDAMED SRN
- CN-MF-000012338
- Authorised Representative
- Luxus Lebenswelt GmbH DE-AR-000005110
Sources (5)
- EUDAMED 4e5bbe0c-3907-421d-b143-b0a36a4181e6 61 fields · synced Sep 18, 2026
- EUDAMED 6d4643d7-3bec-4d5e-b12f-6f64290dfc60 61 fields · synced May 18, 2026
- EUDAMED 0c70b1ce-875f-4d16-baf0-121d4a958a05 61 fields · synced May 19, 2026
- EUDAMED 890ca93d-7f71-44b8-876c-c39a7ed82c82 61 fields · synced May 19, 2026
- EUDAMED 64a20c6e-4f33-4771-a022-1d5f11a34da7 61 fields · synced May 19, 2026