Skip to content

NeoBase 2 Non-derivatized MSMS Kit

by Wallac Oy, Subsidiary of Perkinelmer, Inc.

510(k) K173568Ref 3044-0010

Active European Union and United States

CE IVDR CE IVDD 510(k)

Valid until

Not listed

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 19 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K173568↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), synced 19 Oct 2026. What this means

Regulatory status

as of registry sync 19 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR EUDAMED NumberB-06438147356805 Basic UDI-DI 06438147356805UDI-DIDate22 Aug 2022RegisteredStatusActive
European UnionCE/IVDD EUDAMED NumberB-06438147356805 Basic UDI-DI 06438147356805UDI-DIDate22 Aug 2022RegisteredStatusActive
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK173568 Date4 Sep 2018ClearedStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 19 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/IVDR, CE/IVDD Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 510(k)

Model / Reference
3044-0010
Primary DI / UDI-DI
06438147356805
Basic UDI-DI
B-06438147356805, 6438147MSMS_NeoBase24D
510(k) Number
FDA Product Code
NQL
EMDN Code
W01010499 Multiple clin. chem lab reagents - other
Device Class
Class IVD Annex II List B EUDAMED
Class C EUDAMED
Class II 510(k)
Regulation
21 CFR Part 862.1055
EU market of registration
Finland
Advisory Committee
Clinical Chemistry
FDA Decision
SESE Substantially Equivalent

Truth per registry

2 sources · 1 field differs

FieldEUDAMED510(k)
Device ClassEUDAMED
Class IVD Annex II List B
Class C
510(k)
Class II

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The NeoBase 2 Non-derivatized MSMS Kit is a tandem mass spectrometry system designed for the quantitative analysis of free amino acids, carnitines, and acylcarnitines. It is classified as a test system under the nomenclature for clinical chemistry, enabling comprehensive metabolic screening in newborns and other patient populations.

This kit is intended for single-use in laboratory settings and requires no derivatization prior to analysis. Supplied as a reagent kit, it is regulated under the FDA 510(k) pathway (K173568) and complies with In Vitro Diagnostic Device Directives (IVDD) and Regulations (IVDR). The device is not MRI-safe, and storage conditions must adhere to manufacturer guidelines to maintain stability and performance.

Other devices from Wallac Oy, A Subsidiary of Perkinelmer, Inc.

Questions

AI-generated answers, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the NeoBase 2 Non-derivatized MSMS Kit used for?

    The kit is designed for quantitative analysis of free amino acids, carnitines, and acylcarnitines, enabling comprehensive metabolic screening in newborns and other patient populations.

  • Is the NeoBase 2 kit reusable or single-use?

    The kit is intended for single-use in laboratory settings and requires no derivatization prior to analysis.

  • What regulatory approvals does the NeoBase 2 kit have?

    The kit is regulated under the FDA 510(k) pathway (K173568) and complies with In Vitro Diagnostic Device Directives (IVDD) and Regulations (IVDR).

  • How should the NeoBase 2 kit be stored?

    Storage conditions must adhere to manufacturer guidelines to maintain stability and performance, and the device is not MRI-safe.

Properties

  • Human Tissues
  • Reagent
  • Professional Testing

Other properties (8)

  • Sterile: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No