Devices

Name Classification Manufacturer Risk Class Country Source
Navigation System II - Cart 7700-100-000 / 7700-101-201 Neurological Devices Stryker Navigation,Stryker Leibinger GmbH & Co. KG Stryker Leibinger GmbH & Co. KG Finland
Access Immunoassay System: 81600, R81600, Access 2 Immunoassay System, 81600N: 386220, A12900, A69186, A65531, Synchron LXi 725 Clinical System: A15642, A15662, UniCel DxC 600i Synchron Access Clinical System: A25640, , Beckman Coulter Inc. Finland
Access Immunoassay Systems Access PAPP-A (IVD) QC Beckman Coulter Inc. Finland
UniCel® DxC 600/800 with Software 5.0.11 Synchron Access®Clinical Systems Beckman Coulter Inc. Finland
Access Immunoassay Systems* Access hLH Calibrators ks.ilm. Beckman Coulter Inc. Finland
Access Immunoassay System, Access 2 Immunoassay System, Synchron LXi 725 Clinical System, UniCel DxC 600i Synchron Access Clinical System Beckman Coulter Inc. Finland
Folate Calibrator Beckman Coulter Inc. Finland
UniCel® DxC 660i, UniCel® DxC 680i, UniCel® DxC 860i, UniCel®DxC 880i Synchron® Access® Clinical Systems Beckman Coulter Inc. Finland
CYTO-STAT® tetraCHROME™ CD45-FITC/CD4-RD1/CD8-ECD/CD3-PC5, Part no. 6607013, CYTO-STAT® tetraCHROME™ CD45-FITC/CD56-RD1/CD19-ECD/CD3-PC5, Part No. 6607073, TetraCXP Software System, Part No. A40051 Beckman Coulter Inc. Finland
Synchron LX20, Synchron LXi 725, Synchron LX20 PRO Beckman Coulter Inc. Finland
Synchron® Systems Modular Glucose (GLUCm) Reagent Beckman Coulter Inc. Finland
Access Immunoassay Systems Enhanced AccuTnl Reagent Beckman Coulter Inc. Finland
Access® Immunoassay Systems HBs Ab QC Beckman Coulter Inc. Finland
Access® Immunoassay Systems Progesterone (33550) and Access® Immunoassay Systems Cortisol (33600) Beckman Coulter Inc. Finland
UniCel® DxC 600, UniCel® DxC 600 PRO, UniCel® DxC 600i, UniCel® DxC 800, UniCel® DxC 800 PRO, UniCel® DxC 880i, UniCel® DxC 860i, UniCel® DxC 680i, UniCel® DxC 660i Clinical Chemistry and Clinical Toxicology Devices Beckman Coulter Inc. Finland
Access® Immunoassay Systems Estradiol Beckman Coulter Inc. Finland
PK7200 Blood Grouping System Beckman Coulter Inc. Finland
Coulter LH 500 Analyser Beckman Coulter Inc. Finland
Access® Immunoassay Systems Enhanced AccuTnI Reagent Beckman Coulter Inc. Finland
UniCel® DxH™ 800 Coulter® Cellular Analysis System (629029) Beckman Coulter Inc. Finland
COULTER® PrepPlus (286600), COULTER® PrepPlus 2 (378600) Beckman Coulter Inc. Finland
Unicel® DxH™ 800 Coulter® Cellular Analysis System (PN 629029) Beckman Coulter Inc. Finland
UniCel® Dxl 800 and 600 Access® Immunoassay Systems, UniCel® DxC 880i, 860i, 660i and 680i SYNCHRON® Access® Clinical Systems Beckman Coulter Inc. Finland
PK7300 Blood Grouping System Beckman Coulter Inc. Finland
DePuy DNP Anatomic Fracture Repair System DePuy International Limited Finland