← Back to catalogue
SARS-CoV-2 Neutralizing Antibody Detection Kit (Latex immunochromatography-bloc…
EUDAMEDClass IVD devices for self-testing (EU MDR)
Ref DXK007-1
Identity
- Device Name
- SARS-CoV-2 Neutralizing Antibody Detection Kit (Latex immunochromatography-blocking sandwich method) EUDAMED
- Model / Reference
- DXK007-1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975379900005 EUDAMED
- Basic UDI-DI
- B-06975379900005 EUDAMED
- EMDN Code
- W0105040519 EUDAMED
Classification
- Device Class
- Class IVD devices for self-testing EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
Yes
EUDAMED
Near-Patient Testing
Yes
EUDAMED
Professional Testing
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
SARS-CoV-2 Neutralizing Antibody Detection Kit (Latex immunochromatography-bloc… by Nanjing Genscript Diagnostics Technology Co., Ltd. — Class IVD devices for…
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-06975379900005 | Class IVD devices for self-testing | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Nanjing Genscript Diagnostics Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000025148
- Authorised Representative
- Eunitor GmbH DE-AR-000005081
Sources (1)
- EUDAMED 1095a9bf-4652-466b-950b-5676aea4e659 61 fields · synced Jun 17, 2026