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AutoDELFIA Automatic Immunoassay System
EUDAMEDFDA UDIClass A (EU MDR)
Ref 1235-5110
by Wallac Oy
Identity
- Trade Name
- AutoDELFIA Automatic Immunoassay System EUDAMEDFDA UDI
- Generic Name
- Fluorescent immunoassay analyser IVD, laboratory FDA UDI
- Device Name
- AutoDELFIA Automatic Immunoassay System EUDAMEDThe AutoDELFIA® system (Sample Processor and Plate Processor) is intended to be used as an aid in screening with associated AutoDELFIA® reagent kits for neonatal screening and prenatal screening. It is an automatic immunoassay system designed to automatically perform assays using the proven and widely used method of time-resolved fluorometry. It is intended for in vitro quantitative determination of analytes as described by the associated assays. The function, specific disorder, condition or risk factor to be identified, the specimen type, and testing population are based on and described within the intended purpose of the applicable assay. The AutoDELFIA® system is intended to be used by trained laboratory personnel. FDA UDI
- Model / Reference
- 1235-5110 EUDAMEDFDA UDI
- Description
- The AutoDELFIA® system (Sample Processor and Plate Processor) is intended to be used as an aid in screening with associated AutoDELFIA® reagent kits for neonatal screening and prenatal screening. It is an automatic immunoassay system designed to automatically perform assays using the proven and widely used method of time-resolved fluorometry. It is intended for in vitro quantitative determination of analytes as described by the associated assays. The function, specific disorder, condition or risk factor to be identified, the specimen type, and testing population are based on and described within the intended purpose of the applicable assay. The AutoDELFIA® system is intended to be used by trained laboratory personnel. FDA UDI
Identifiers
- Catalog Number
- 1235-5110 FDA UDI
- Primary DI / UDI-DI
- 06438147335008 EUDAMEDFDA UDI
- Basic UDI-DI
- 6438147AutoDELFIA_PPP2 EUDAMED
- FDA Product Code
- KHO FDA UDI
- EMDN Code
- W0201020102 AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE ROUTINE (Throughput > 100 and <= 250 test/h) 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
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
AutoDELFIA Automatic Immunoassay System 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 | 6438147AutoDELFIA_PPP2 | 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 6da27e5c-3147-4e70-946f-4cf5c3746ce1 61 fields · synced Jun 18, 2026
- FDA UDI a2c36297-3018-46aa-a5ea-ff3f16ccd6b9 34 fields · synced May 30, 2026