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Anti-dsDNA IgG Detection Kit（Magnetic Solid Phase Chemiluminescent Immunoassay）
EUDAMEDClass IVD General (EU MDR)
Ref 200 Tests/kit（DR1158-3）Model 200 Tests/kitRef 50 Tests/kit（DR1158-1）Model 50 Tests/kitRef 100 Tests/kit（DR1158-2）Model 100 Tests/kit
Identity
- Trade Name
- Anti-dsDNA IgG Detection Kit（Magnetic Solid Phase Chemiluminescent Immunoassay） EUDAMED
- Device Name
- Anti-dsDNA IgG Detection Kit（Magnetic Solid Phase Chemiluminescent Immunoassay） EUDAMED
- Model / Reference
- 200 Tests/kit EUDAMED200 Tests/kit（DR1158-3） EUDAMED50 Tests/kit EUDAMED50 Tests/kit（DR1158-1） EUDAMED100 Tests/kit EUDAMED100 Tests/kit（DR1158-2） EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974969982995 EUDAMED06974969982971 EUDAMED06974969982988 EUDAMED
- Basic UDI-DI
- B-06974969982995 EUDAMEDB-06974969982971 EUDAMEDB-06974969982988 EUDAMED
- EMDN Code
- W0102100105 DS DNA - ANTIBODIES 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
Anti-dsDNA IgG Detection Kit（Magnetic Solid Phase Chemiluminescent Immunoassay） by Biobase Diagnostic Technology (Shandong) Co., Ltd. — Class IVD General…
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-06974969982995 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Biobase Diagnostic Technology (Shandong) Co., Ltd.
- EUDAMED SRN
- CN-MF-000025964
- Authorised Representative
- Luxus Lebenswelt GmbH DE-AR-000005110
Sources (3)
- EUDAMED 4995ca90-d661-4b90-ae1e-e1a2296859d9 61 fields · synced Oct 6, 2026
- EUDAMED 915eeb26-c755-4bfc-a8c3-f09ec2fe9ffd 61 fields · synced May 18, 2026
- EUDAMED 61e57289-452d-4616-8493-cd8ca8d6f37e 61 fields · synced May 18, 2026