NeoBase Succinylacetone Assay Solution

EUDAMEDFDA UDI

Class IVD General (EU MDR)

Ref 3042-0020

by Wallac Oy

Identity

Trade Name: NeoBase Succinylacetone Assay Solution EUDAMEDFDA UDI
Generic Name: Multiple amino acid/carnitine metabolite IVD, kit, mass spectrometry FDA UDI
Device Name: NeoBase Succinylacetone Assay Solution EUDAMED
The NeoBase™ Succinylacetone Assay Solution is intended for in vitro diagnostic use with the NeoBase Non-derivatized MSMS Kit and the NeoBase non-derivatized Assay Solutions. The NeoBase™ Succinylacetone Assay Solution is used for the measurement and evaluation of succinylacetone concentration from blood samples dried on filter paper (DBS). FDA UDI
Model / Reference: 3042-0020 EUDAMEDFDA UDI
Description: The NeoBase™ Succinylacetone Assay Solution is intended for in vitro diagnostic use with the NeoBase Non-derivatized MSMS Kit and the NeoBase non-derivatized Assay Solutions. The NeoBase™ Succinylacetone Assay Solution is used for the measurement and evaluation of succinylacetone concentration from blood samples dried on filter paper (DBS). FDA UDI

Identifiers

Catalog Number: 3042-0020 FDA UDI
Primary DI / UDI-DI: 06438147295708 EUDAMEDFDA UDI
Basic UDI-DI: B-06438147295708 EUDAMED
510(k) Number: K083130 FDA UDI
K093916 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 EUDAMED
Class II FDA UDI
Regulation Number: 862.1055 FDA UDI
Market of Registration: Finland EUDAMED
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

EUDAMEDFDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Human Tissues

EUDAMED

Animal Tissues

EUDAMED

Microbial Substances

EUDAMED

Reagent

Yes

EUDAMED

Self Testing

EUDAMED

Near-Patient Testing

EUDAMED

Professional Testing

Yes

EUDAMED

Companion Diagnostics

EUDAMED

Surgical Instrument

EUDAMED

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Nucleic acid extraction/isolation kit IVD

NeoBase 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

European Union Active

CE/IVDD

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	CE/IVDD	B-06438147295708	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 14a3330d-e4cd-4d62-a0d8-7419d1c83ca1 61 fields · synced Jul 9, 2026
FDA UDI 312a0807-2d2d-4315-8b69-c7f534ac573d 36 fields · synced May 27, 2026