← Back to catalogue
SARS-CoV-2(COVID-19)Antibody Rapid Detection Kit(Lateral Flow Method)
EUDAMEDClass IVD General (EU MDR)
Ref 18-02-0130Model 25 Tests/kitRef 18-02-0021Model 50 Tests/kitRef 18-02-0022Model 100 Tests/kit
Identity
- Trade Name
- SARS-CoV-2(COVID-19)Antibody Rapid Detection Kit(Lateral Flow Method) EUDAMED
- Device Name
- SARS-CoV-2(COVID-19)Antibody Rapid Detection Kit(Lateral Flow Method) EUDAMED
- Model / Reference
- 25 Tests/kit EUDAMED18-02-0130 EUDAMED50 Tests/kit EUDAMED18-02-0021 EUDAMED100 Tests/kit EUDAMED18-02-0022 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974674891490 EUDAMED06974674891506 EUDAMED06974674891513 EUDAMED
- Basic UDI-DI
- B-06974674891490 EUDAMEDB-06974674891506 EUDAMEDB-06974674891513 EUDAMED
- EMDN Code
- W0105099099 VIROLOGY - RT & POC - OTHER EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMEDEUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
SARS-CoV-2(COVID-19)Antibody Rapid Detection Kit(Lateral Flow Method) by Shenzhen Zijian Biotechnology 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-06974674891490 | Class IVD General | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Shenzhen Zijian Biotechnology Co., Ltd
- EUDAMED SRN
- CN-MF-000022829
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (3)
- EUDAMED 47a05d37-040f-4484-a4f8-171d99f8e6b8 61 fields · synced Oct 7, 2026
- EUDAMED 334c4303-7ded-4fc7-8604-780bbc75de57 61 fields · synced May 16, 2026
- EUDAMED ed2d88bb-5757-4132-9496-4a2ef4f3e38e 61 fields · synced May 17, 2026