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SARS-CoV-2 Neutralization Antibody Detection Kit (ELISA),
EUDAMEDClass IVD General (EU MDR)
Ref EL-0001-96
Identity
- Trade Name
- SARS-CoV-2 Neutralization Antibody Detection Kit (ELISA), EUDAMED
- Device Name
- SARS-CoV-2 Neutralization Antibody Detection Kit (ELISA), EUDAMED
- Model / Reference
- EL-0001-96 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971042229626 EUDAMED
- Basic UDI-DI
- B-06971042229626 EUDAMED
- EMDN Code
- W0105040619 EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- France 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 Detection Kit (ELISA), by Shanghai Zj Bio-Tech 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-06971042229626 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Shanghai Zj Bio-Tech Co., Ltd
- EUDAMED SRN
- CN-MF-000017861
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (1)
- EUDAMED 7143fa9e-2ab8-4165-8c45-e2c73776755e 61 fields · synced Jul 10, 2026