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FLEX Monoclonal Mouse Anti-Human p16, Clone JC8, Ready-to-Use (Dako Omnis)
EUDAMEDClass C (EU MDR)
Ref GA783Model GA78361-2
Identity
- Trade Name
- FLEX Monoclonal Mouse Anti-Human p16, Clone JC8, Ready-to-Use (Dako Omnis) EUDAMED
- Device Name
- FLEX Monoclonal Mouse Anti-Human p16, Clone JC8, Ready-to-Use (Dako Omnis) EUDAMED
- Model / Reference
- GA78361-2 EUDAMEDGA783 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05700573004546 EUDAMED
- Basic UDI-DI
- 570057R0301P3007C008501N9 EUDAMED
- EMDN Code
- W0102030124 CANCER ANTIGEN P16 EUDAMED
Classification
- Device Class
- Class C EUDAMED
- Market of Registration
- Denmark EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
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
No
EUDAMED
FLEX Monoclonal Mouse Anti-Human p16, Clone JC8, Ready-to-Use (Dako Omnis) by Agilent Technologies Singapore (International) Pte Ltd — Class C — IVDR — listed…
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 | 570057R0301P3007C008501N9 | Class C | Active |
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Manufacturer
- EUDAMED SRN
- SG-MF-000014448
- Authorised Representative
- Agilent Technologies Denmark ApS DK-AR-000001443
Sources (1)
- EUDAMED ff3fa228-1122-474e-abc7-2081f6061882 61 fields · synced Oct 6, 2026