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Golimumab Determination Kit (Fluorescence Immunochromatographic Assay)
EUDAMEDClass B (EU MDR)
Ref P11425Model 25 tests/box
Identity
- Trade Name
- Golimumab Determination Kit (Fluorescence Immunochromatographic Assay) EUDAMED
- Device Name
- Golimumab Determination Kit (Fluorescence Immunochromatographic Assay) EUDAMED
- Model / Reference
- 25 tests/box EUDAMEDP11425 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942293581863 EUDAMED
- Basic UDI-DI
- 697518250P114256E EUDAMED
- Direct Marketing DI
- 06942293581863 EUDAMED
- EMDN Code
- W0102080799 AUTOIMMUNE DISEASE TDM - OTHER EUDAMED
Classification
- Device Class
- Class B EUDAMED
- Market of Registration
- Italy 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
New Device
Yes
EUDAMED
The Golimumab Determination Kit (Fluorescence Immunochromatographic Assay) is a medical device designed to accurately detect and measure the presence of golimumab, a monoclonal antibody used in the treatment of rheumatoid arthritis. This reagent-based test provides reliable results for clinical diagnostic purposes.
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 | 697518250P114256E | Class B | Active |
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Manufacturer
- Manufacturer
- Beijing Diagreat Biotechnologies Co., Ltd.
- EUDAMED SRN
- CN-MF-000019511
- Authorised Representative
- Medunion S.L. ES-AR-000019366
Sources (1)
- EUDAMED 00a8ec80-19f4-49c3-9955-a0d36226373a 61 fields · synced Jul 27, 2026