— a COULTER Declaration of Conformity Beckman Coulter, Inc. hereby ensures and declares that the product(s) listed below comply with the requirement of the European Union In-vitro Diagnostics Medical Device Directive 98/79/EC. Beckman Coulter, Ine. assure et delare parla présente que les) produits) lst(s ci-dessous sont conformes aux texigences de la directive européenne 98/79/CE relative aux dspositifs médicaux de diagnostic in vito. Beckman Coulter, Ine. dichiara ed assicura che i prodotti qui elencati sono conform a requis della direttiva comunitaria 98/99/CE relativa ai disposivi medico-diagnostici in vitro, ‘Beckman Coulter, Inc. versichect und eeklict hiermit, da die im Folgenden aufgetuhrten Produekte den Auflagen ddr IVD-Richlinie fir In-viteo-Diagnostika der Europtischen Union (98/79/EC) entsprecten. ‘Beckman Coulter, Ic, aseguray declara que los productos listadoes a continvacién cumpen con tos requistos establecidos en la directiva. 98/79/EC de la Comunided Europea par dispositivos meicos de diagnstco in vitro. Product(s) /Produkie) /Prodottol) / Produit(s) / Producto(s| COULTER 5C Cell Control, Part Number 7547011 ‘Authorized Representative (AR) Beckman Coulter Eurocenter S.A 22, rue Juste-Oliver ‘case Postale 1044 CH= 1260 Nyon 1, Switzerland Tel: +41 (0) 22 3645 36 11 Conformity Assessment Procedure Annex ll- Self Declared VA Radha Goolabsingh, RA Senior Manager Date Beckman Coulter, Ine Document Control 250°. Kraemer Bla, Issue Date: September 10, 2003 Brea, CAS2821 USA Revision Loval: 6.0 Revision Date: January 8, 2018 Starting Lot #: 1008266F Filename: 754701 1DEC