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IgG4 Assay Kit (Chemiluminescent Immunoassay)
EUDAMEDClass IVD General (EU MDR)
Ref DB2101Model 2×50 tests/box Calibrator: 0.5mL×2; Quality control: 1.0mL×2
Identity
- Trade Name
- IgG4 Assay Kit (Chemiluminescent Immunoassay) EUDAMED
- Device Name
- IgG4 Assay Kit (Chemiluminescent Immunoassay) EUDAMED
- Model / Reference
- 2×50 tests/box Calibrator: 0.5mL×2; Quality control: 1.0mL×2 EUDAMEDDB2101 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942028501760 EUDAMED
- Basic UDI-DI
- B-06942028501760 EUDAMED
- EMDN Code
- W0102010105 IMMUNOGLOBULIN G EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Spain 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
Category: Human immunoglobulin G (IgG) animal conjugate antibody reagent IVD
IgG4 Assay Kit (Chemiluminescent Immunoassay) by Sichuan Orienter Biotechnology Co., Ltd. — Class IVD General — IVDD — listed in EUDAMED
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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-06942028501760 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Sichuan Orienter Biotechnology Co., Ltd.
- EUDAMED SRN
- CN-MF-000003026
- Authorised Representative
- Medunion S.L. ES-AR-000019366
Sources (1)
- EUDAMED 1e8e93ad-706b-4ecd-911b-c02e0c2c3f12 61 fields · synced Jul 9, 2026