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Anti-Cardiolipin IgG/IgM Assay Kit (Fluorescence Immunoassay)
EUDAMEDClass IVD General (EU MDR)
Ref 20T
Identity
- Trade Name
- Anti-Cardiolipin IgG/IgM Assay Kit (Fluorescence Immunoassay) EUDAMED
- Device Name
- Anti-Cardiolipin IgG/IgM Assay Kit (Fluorescence Immunoassay) EUDAMED
- Model / Reference
- 20T EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975424221833 EUDAMED
- Basic UDI-DI
- B-06975424221833 EUDAMED
- EMDN Code
- W0102100504 APLS SCREENING (OR ANTI-CARDIOLIPIN / ANTI-B2-GLYCOPROTEIN COMBITEST) EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Austria 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-Cardiolipin IgG/IgM Assay Kit (Fluorescence Immunoassay) by DiYaLab ZJG Biotech Co., Ltd — Class IVD General — CE/MDR — listed in EUDAMED
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | B-06975424221833 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- DiYaLab ZJG Biotech Co., Ltd
- EUDAMED SRN
- CN-MF-000048648
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED a278b9b6-b0a5-499b-bf13-a4b7978fe915 61 fields · synced Oct 7, 2026