Identity
- Trade Name
- Victor2 D EUDAMEDFDA UDI
- Generic Name
- Fluorescent immunoassay analyser IVD, laboratory FDA UDI
- Device Name
- Victor2 D EUDAMEDVICTOR2 D will primarly be used for measuring test kits supplied by Wallac especially for neonatal tests. Secondly VICTOR2 D can also be used for other measurements of TRF and prompt fluorescence. The user is a laboratory running screening on newborns or a general clinical chemistry lab running different hormones on blood samples. FDA UDI
- Model / Reference
- 1420-020 EUDAMEDFDA UDI
- Description
- VICTOR2 D will primarly be used for measuring test kits supplied by Wallac especially for neonatal tests. Secondly VICTOR2 D can also be used for other measurements of TRF and prompt fluorescence. The user is a laboratory running screening on newborns or a general clinical chemistry lab running different hormones on blood samples. FDA UDI
Identifiers
- Catalog Number
- 1420-020 FDA UDI
- Primary DI / UDI-DI
- 06438147116126 EUDAMEDFDA UDI
- Basic UDI-DI
- 6438147Victor_DYK EUDAMED
- FDA Product Code
- KHO FDA UDI
- EMDN Code
- W02010299 IMMUNOCHEMISTRY INSTRUMENTS - OTHER EUDAMED
- GMDN Term
- Fluorescent immunoassay analyser IVD, laboratory FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass I FDA UDI
- Regulation Number
- 862.2560 FDA UDI
- Market of Registration
- Finland 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
Yes
EUDAMED
New Device
No
EUDAMED
Prescription Use
Yes
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Victor2 D by Wallac Oy — Class A — IVDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/IVDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 6438147Victor_DYK | Class A | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class A | Pending data |
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Manufacturer
- Manufacturer
- Wallac Oy
- EUDAMED SRN
- FI-MF-000022620
Sources (2)
- EUDAMED 2bf513d6-ba88-40db-a9fa-92d1b76849ba 61 fields · synced Jun 19, 2026
- FDA UDI d0812ce8-c9a4-4d7f-babf-11e6612d6eed 34 fields · synced May 30, 2026