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Anti-FITC-AP CISH Accessory Kit (Dako Omnis), Box A
EUDAMEDClass A (EU MDR)
Ref K5899Model K589911-21
Identity
- Trade Name
- Anti-FITC-AP CISH Accessory Kit (Dako Omnis), Box A EUDAMED
- Device Name
- Anti-FITC-AP CISH Accessory Kit (Dako Omnis), Box A EUDAMED
- Model / Reference
- K589911-21 EUDAMEDK5899 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05700571112861 EUDAMED
- Basic UDI-DI
- 570057R0801P3004A040600SG EUDAMED
- EMDN Code
- W01030703 DNA IN SITU HYBRIDISATION REAGENTS EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Denmark EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
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
Anti-FITC-AP CISH Accessory Kit (Dako Omnis), Box A by Agilent Technologies, Inc. — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS
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 | 570057R0801P3004A040600SG | Class A | Active |
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Manufacturer
- Manufacturer
- Agilent Technologies, Inc.
- EUDAMED SRN
- US-MF-000009385
- Authorised Representative
- Agilent Technologies Denmark ApS DK-AR-000001443
Sources (1)
- EUDAMED b6245820-fee8-4a64-afb9-c10b0ce17314 61 fields · synced Jun 19, 2026