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Dako Omnis Clean Liquid System Hardware
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref GC122Model GC12230
Identity
- Trade Name
- Dako Omnis Clean Liquid System Hardware EUDAMEDFDA UDI
- Generic Name
- Assay container IVD, reusable FDA UDI
- Device Name
- Dako Omnis Clean Liquid System Hardware EUDAMEDFDA UDI
- Model / Reference
- GC122 EUDAMEDFDA UDIGC12230 EUDAMED
- Description
- Dako Omnis Clean Liquid System Hardware FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05700575014017 EUDAMEDFDA UDI
- Basic UDI-DI
- 570057P3007P3010A087701R6 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 Clean Liquid System Hardware 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 (3)
- FDA UDI ad5cc4db-f335-4942-8397-d104c21cdc96 36 fields · synced Aug 1, 2026
- EUDAMED dfcc7ffe-04f5-4342-a73a-f460496aaa0c 61 fields · synced Jul 28, 2026
- EUDAMED 4ee0977e-7945-4baf-822a-95c2b0e26f57 61 fields · synced Aug 1, 2026