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NeoBase Non-derivatized Assay Solutions
EUDAMEDFDA UDIClass IVD Annex II List B (EU MDR)
Ref 3041-0020
by Wallac Oy
Identity
- Trade Name
- NeoBase Non-derivatized Assay Solutions EUDAMEDFDA UDI
- Generic Name
- Multiple amino acid/carnitine metabolite IVD, kit, mass spectrometry FDA UDI
- Device Name
- NeoBase Non-derivatized Assay Solutions EUDAMEDThis reagent package is intended for sample processing in the assay of in vitro measurement and evaluation of the concentrations of amino acids, succinylacetone and acylcarnitines in dried blood spot samples (DBS) on filter paper. This reagent package is used together with the NeoBase Non-derivatized MSMS Kit and the NeoBase Succinylacetone Assay Solution. FDA UDI
- Model / Reference
- 3041-0020 EUDAMEDFDA UDI
- Description
- This reagent package is intended for sample processing in the assay of in vitro measurement and evaluation of the concentrations of amino acids, succinylacetone and acylcarnitines in dried blood spot samples (DBS) on filter paper. This reagent package is used together with the NeoBase Non-derivatized MSMS Kit and the NeoBase Succinylacetone Assay Solution. FDA UDI
Identifiers
- Catalog Number
- 3041-0020 FDA UDI
- Primary DI / UDI-DI
- 06438147295692 EUDAMEDFDA UDI
- Basic UDI-DI
- B-06438147295692 EUDAMED6438147MSMS_NeoBaseSolS5 EUDAMED
- FDA Product Code
- NQL FDA UDI
- EMDN Code
- W01019001 BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC) EUDAMED
- GMDN Term
- Multiple amino acid/carnitine metabolite IVD, kit, mass spectrometry FDA UDI
Classification
- Device Class
- Class IVD Annex II List B EUDAMEDClass A EUDAMEDClass II FDA UDI
- Regulation Number
- 862.1055 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
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
No
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
NeoBase Non-derivatized Assay Solutions by Wallac Oy — Class IVD Annex II List B — IVDR, IVDD, FDA UDI — listed in EUDAMED, FDA GUDID
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/IVDR
European Union Active
CE/IVDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | B-06438147295692 | Class IVD Annex II List B | Active |
| EUDAMED | European Union | CE/IVDD | B-06438147295692 | Class IVD Annex II List B | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IVD Annex II List B | Pending data |
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Manufacturer
- Manufacturer
- Wallac Oy
- EUDAMED SRN
- FI-MF-000022620
Sources (3)
- EUDAMED 1dfb5be2-3485-4310-86f8-678079b003c4 61 fields · synced Jun 19, 2026
- EUDAMED 66cb3204-1f03-4f27-ae40-e302d76048b2 61 fields · synced May 17, 2026
- FDA UDI aeac7032-350b-42f3-b05b-e343587c5397 36 fields · synced May 30, 2026