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NeoBase 2 Non-derivatized Assay Solutions
EUDAMEDFDA UDIClass IVD Annex II List B (EU MDR)
Ref 3045-0010
by Wallac Oy
Identity
- Trade Name
- NeoBase 2 Non-derivatized Assay Solutions EUDAMEDFDA UDI
- Generic Name
- Multiple amino acid/carnitine metabolite IVD, kit, mass spectrometry FDA UDI
- Device Name
- NeoBase 2 Non-derivatized Assay Solutions EUDAMEDNeoBase™ 2 Non-derivatized Assay Solutions are intended for in vitro diagnostic use with the NeoBase 2 Non-derivatized MSMS kit to extract target analytes from blood samples dried on filter paper and to carry target analytes to the MSMS system. FDA UDI
- Model / Reference
- 3045-0010 EUDAMEDFDA UDI
- Description
- NeoBase™ 2 Non-derivatized Assay Solutions are intended for in vitro diagnostic use with the NeoBase 2 Non-derivatized MSMS kit to extract target analytes from blood samples dried on filter paper and to carry target analytes to the MSMS system. FDA UDI
Identifiers
- Catalog Number
- 3045-0010 FDA UDI
- Primary DI / UDI-DI
- 06438147348107 EUDAMEDFDA UDI
- Basic UDI-DI
- B-06438147348107 EUDAMED6438147MSMS_NeoBase2SQA EUDAMED
- 510(k) Number
- K173568 FDA UDI
- 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
Yes
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
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
NeoBase 2 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-06438147348107 | Class IVD Annex II List B | Active |
| EUDAMED | European Union | CE/IVDD | B-06438147348107 | 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 6962a982-e2bc-4661-8055-b34941099d4a 61 fields · synced Jul 11, 2026
- EUDAMED 05c0781c-44b0-47de-8919-424a49104d5c 61 fields · synced May 19, 2026
- FDA UDI 35dab8d3-b71d-41be-998f-d87a26fead89 36 fields · synced May 30, 2026