Lp-PLA2 Calibrator

Model / Reference

PLA2-CAL

Primary DI / UDI-DI

05391523441032

Basic UDI-DI

B-05391523441032

EMDN Code

W0102152204 Cardiac marker standards and calibrators

Device Class

Class IVD General

Market of Registration

Ireland

EUDAMED SRN

IE-MF-000001822

• Multichem CSF

  Class C

  CE/IVDR GUDID on market

• Lp-PLA Reagent

  IVD General

  CE/IVDD

• Multichem Ia and Ia Plus

  Class I

  FDA 510(k) K132091 Active Cleared 20 Sep 2013

• Multichem ID-G (09339892190); Multichem ID-G (SR102G); Multichem ID-G (SR102MG); Multichem ID-GNeg (09339906190); Multichem ID-GNeg (SR102N); Multichem ID-GNeg (SR102MN)

  Class II

  FDA 510(k) K242492 Active Cleared 30 Dec 2025

• Multichem S Plus / S Plus (Assayed)

  Class I

  FDA 510(k) K132751 Active Cleared 22 Oct 2013

• Multichem Wbt

  Class I

  FDA 510(k) K132174 Active Cleared 20 Sep 2013

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