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  • Dispositivo 995
  • Fabricante 138
  • Evento 124969
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Nombre Clasificación Fabricante Nivel de riesgo País Fuente
VITROS 3600 Immunodiagnostics System and VITROS 5600 Integrated System, software version 3.2.2 and below. An in vitro diagnostic medical device (IVD) Clinical Chemistry and Clinical Toxicology Devices Ortho-Clinical Diagnostics Australia DHTGA
VITROS Immunodiagnostic Products AFP Reagent Packs and Calibrators. An in vitro diagnostic medical device (IVD) Ortho-Clinical Diagnostics Australia DHTGA
VITROS Immunodiagnostic Products HBsAg Controls. An in vitro diagnostic medical device (IVD). Ortho-Clinical Diagnostics Australia DHTGA
VITROS Immunodiagnostic Products Estradiol Reagent Pack (used for the determination of estradiol in human serum). An in vitro diagnostic medical device (IVD) Ortho-Clinical Diagnostics Australia DHTGA
VITROS Chemistry Products Slide Assays - GLU, LAC, TRIG, URIC. An in vitro diagnostic medical device (IVD) Ortho-Clinical Diagnostics Australia DHTGA
VITROS Automation Solutions configured with a Thermo Scientific Centrifuge Module. An in vitro diagnostic medical device (IVD) Ortho-Clinical Diagnostics Australia DHTGA
VITROS Immunodiagnostic Products Intact iPTH Reagent Packs & Calibrators (used on VITROS ECi/ECiQ/3600 Immunodiagnostic Systems, & VITROS 5600 Integrated Systems) An in vitro diagnostic medical device (IVD) Ortho-Clinical Diagnostics Australia DHTGA
VITROS Chemistry Products Calibrator Kit 25 (used on VITROS 4600/5600 Systems and with VITROS Chemistry Products dHDL Slides). An in vitro diagnostic medical device (IVD). Ortho-Clinical Diagnostics Australia Pty Ltd Australia DHTGA
VITROS Chemistry Products C-reactive protein (CRP) Slides Ortho-Clinical Diagnostics Australia Pty Ltd Australia DHTGA
VITROS Chemistry Products PHYT Slides used on VITROS 250/350/950/5,1 FS/4600/5600 Systems. An in vitro diagnostic device (IVD). Ortho-Clinical Diagnostics Australia Pty Ltd Australia DHTGA
Reagent Red Blood Cells 0.8% Resolve Panel C. An in vitro diagnostic medical device (IVD). Ortho-Clinical Diagnostics Australia Pty Ltd Australia DHTGA
VITROS Chemistry Products UPRO Slides for measurement of protein in urine (using VITROS 250/350/5,1 FS/4600 and 5600 Systems). An in vitro diagnostic medical device (IVD). Ortho-Clinical Diagnostics Australia Pty Ltd Australia DHTGA
VITROS Chemistry Products Na+ Slides. An in vitro diagnostic medical device (IVD) Clinical Chemistry and Clinical Toxicology Devices Ortho-Clinical Diagnostics Australia Pty Ltd Australia DHTGA
VITROS Chemistry Products VANC Reagent. An in vitro diagnostic medical device (IVD). Ortho-Clinical Diagnostics Australia Pty Ltd Australia DHTGA
VITROS Immunodiagnostic Products NT-proBNP Reagent Pack. An in vitro diagnostic medical device (IVD) Ortho-Clinical Diagnostics Australia Pty Ltd Australia DHTGA
VITROS Chemistry Products PHYT Slides. An in vitro diagnostic medical device (IVD)(utilised with VITROS 250/350/5, 1 FS and 4600 Chemistry Systems and VITROS 5600 Integrated Systems) Ortho-Clinical Diagnostics Australia Pty Ltd Australia DHTGA
VITROS Performance Verifier II. An in vitro diagnostic medical device (IVD) Ortho-Clinical Diagnostics Australia Pty Ltd Australia DHTGA
VITROS Immunodiagnostic Products Signal Reagent. An in vitro diagnostic medical device (IVD) Ortho-Clinical Diagnostics Australia Pty Ltd Australia DHTGA
VITROS Chemistry Products PHYT Slides. An in vitro diagnostic medical device (IVD). Ortho-Clinical Diagnostics Australia Pty Ltd Australia DHTGA
VITROS Chemistry Products Na+ Slides. An in vitro diagnostic medical device (IVD) Ortho-Clinical Diagnostics Australia Pty Ltd Australia DHTGA
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