NeoBase 2 Succinylacetone Assay Solution
EUDAMEDFDA UDIClass IVD General (EU MDR)
by Wallac Oy
Identity
- Trade Name
- NeoBase 2 Succinylacetone Assay Solution EUDAMEDFDA UDI
- Generic Name
- Multiple amino acid/carnitine metabolite IVD, kit, mass spectrometry FDA UDI
- Device Name
- NeoBase 2 Succinylacetone Assay Solution EUDAMEDNeoBase™ 2 Succinylacetone Assay Solution is intended for in vitro diagnostic use with the NeoBase 2 Non-derivatized MSMS kit and the NeoBase2 Non-derivatized Assay Solutions to extract succinylacetone from blood samples dried on filter paper. FDA UDI
- Model / Reference
- 3046-0010 EUDAMEDFDA UDI
- Description
- NeoBase™ 2 Succinylacetone Assay Solution is intended for in vitro diagnostic use with the NeoBase 2 Non-derivatized MSMS kit and the NeoBase2 Non-derivatized Assay Solutions to extract succinylacetone from blood samples dried on filter paper. FDA UDI
Identifiers
- Catalog Number
- 3046-0010 FDA UDI
- Primary DI / UDI-DI
- 06438147356829 EUDAMEDFDA UDI
- Basic UDI-DI
- B-06438147356829 EUDAMED
- 510(k) Number
- K173568 FDA UDI
- FDA Product Code
- NQL FDA UDI
- EMDN Code
- W01019099 CLINICAL CHEMISTRY REAGENTS - OTHER EUDAMED
- GMDN Term
- Multiple amino acid/carnitine metabolite IVD, kit, mass spectrometry FDA UDI
Classification
- Device Class
- Class IVD General 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
Single Use
No
Implantable
No
Contains Latex
No
Human Tissues
No
Animal Tissues
No
Microbial Substances
No
Reagent
Yes
Self Testing
No
Near-Patient Testing
No
Professional Testing
Yes
Companion Diagnostics
No
Surgical Instrument
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
Yes
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Category: Nucleic acid extraction/isolation kit IVD
NeoBase 2 Succinylacetone Assay Solution by Wallac Oy — Class IVD General — IVDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/IVDD
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-06438147356829 | Class IVD General | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IVD General | Pending data |
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Manufacturer
- Manufacturer
- Wallac Oy
- EUDAMED SRN
- FI-MF-000022620
Sources (2)
- EUDAMED b311a870-ff4e-43c6-9fe8-2c5d08dd951e 61 fields · synced Jun 19, 2026
- FDA UDI dd8880c7-97fd-4fca-9cd5-ff04b7320cf7 36 fields · synced May 30, 2026