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DELFIA Wash Concentrate
EUDAMEDFDA UDIClass A (EU MDR)
Ref 1244-114
by Wallac Oy
Identity
- Trade Name
- DELFIA Wash Concentrate EUDAMEDFDA UDI
- Generic Name
- Buffered wash solution IVD FDA UDI
- Device Name
- DELFIA Wash Concentrate EUDAMEDFor use with the DELFIA® Platewash or the AutoDELFIA® automatic immunoassay system. FDA UDI
- Model / Reference
- 1244-114 EUDAMEDFDA UDI
- Description
- For use with the DELFIA® Platewash or the AutoDELFIA® automatic immunoassay system. FDA UDI
Identifiers
- Catalog Number
- 1244-114 FDA UDI
- Primary DI / UDI-DI
- 06438147005291 EUDAMEDFDA UDI
- Basic UDI-DI
- 6438147D_WashConcX2 EUDAMED
- FDA Product Code
- PPM FDA UDI
- EMDN Code
- W01029003 BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC) EUDAMED
- GMDN Term
- Buffered wash solution IVD FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass I FDA UDI
- Regulation Number
- 864.4010 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
Yes
FDA UDI
Human Tissues
No
EUDAMED
Animal Tissues
No
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
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
DELFIA Wash Concentrate 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 | 6438147D_WashConcX2 | 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 3db82248-e08a-4180-873b-9b5708e83fde 61 fields · synced Jul 10, 2026
- FDA UDI 29c9a3b9-3f70-4d3e-8a40-8e0d8781145b 35 fields · synced May 30, 2026