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Dako Omnis DI Water Filling Accessories
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref GC121Model GC12130
Identity
- Trade Name
- Dako Omnis DI Water Filling Accessories EUDAMEDFDA UDI
- Generic Name
- Assay container IVD, reusable FDA UDI
- Device Name
- Dako Omnis DI Water Filling Accessories EUDAMEDFDA UDI
- Model / Reference
- GC121 EUDAMEDFDA UDIGC12130 EUDAMED
- Description
- Dako Omnis DI Water Filling Accessories FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05700575013812 EUDAMEDFDA UDI
- Basic UDI-DI
- 570057P3007P3010A087601QZ EUDAMED
- FDA Product Code
- KPA FDA UDI
- EMDN Code
- W0202059085 VARIOUS PROCESSING INSTRUMENTS FOR HYSTOLOGY / CYTOLOGY - CONSUMABLES EUDAMED
- GMDN Term
- Assay container IVD, reusable FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass I FDA UDI
- Regulation Number
- 864.3800 FDA UDI
- Market of Registration
- Denmark EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Assay container IVD, reusable
Dako Omnis DI Water Filling Accessories by Agilent Technologies Singapore Pte Ltd — Class I — IVDR, FDA UDI — listed in FDA GUDID, EUDAMED
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
IVDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Agilent Technologies Singapore Pte Ltd
Sources (2)
- FDA UDI c09043e4-bb78-4704-9093-a892e4c17ca7 36 fields · synced Oct 6, 2026
- EUDAMED 3c77bb02-b961-4ae2-a2ca-da732ce6275c 61 fields · synced Jul 19, 2026