← Back to catalogue
Nivolumab CLIA kit (Chemiluminescence Immunoassay)
EUDAMEDClass C (EU MDR)
Ref F11435Model 100 tests/box
Identity
- Trade Name
- Nivolumab CLIA kit (Chemiluminescence Immunoassay) EUDAMED
- Device Name
- Nivolumab CLIA kit (Chemiluminescence Immunoassay) EUDAMED
- Model / Reference
- 100 tests/box EUDAMEDF11435 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942293590988 EUDAMED
- Basic UDI-DI
- 697518250F114352F EUDAMED
- Direct Marketing DI
- 06942293590988 EUDAMED
- EMDN Code
- W01020899 THERAPEUTIC DRUG MONITORING - OTHER EUDAMED
Classification
- Device Class
- Class C 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
Nivolumab CLIA kit (Chemiluminescence Immunoassay) by Beijing Diagreat Biotechnologies Co., Ltd. — Class C — IVDR — 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 | 697518250F114352F | Class C | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Beijing Diagreat Biotechnologies Co., Ltd.
- EUDAMED SRN
- CN-MF-000019511
- Authorised Representative
- Medunion S.L. ES-AR-000019366
Sources (1)
- EUDAMED c4485a81-a3ef-4272-a341-79f66d1572c8 61 fields · synced Oct 6, 2026