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이름 분류 제조사 위험등급 국가 출처
AMH Gen II ELISA (clinical chemistry substrate, Anti-Mullerian Hormone assay). An in vitro diagnostic medical device (IVD). Beckman Coulter Australia Pty Ltd Australia
Access Immunoassay System, Access 2 Immunoassay System, Synchron LXi 725 Clinical System, UniCel 600i Synchron Access Clinical System. In vitro diagnostic medical devices (IVD) Beckman Coulter Australia Pty Ltd Australia
Access hLH Calibrators used with Access Immunoassay Systems. An in vitro diagnostic medical device (IVD) Beckman Coulter Australia Pty Ltd Australia
AU5800 diluted detergent tank used with AU5800 Clinical Chemistry Analyser. An in vitro diagnostic medical device (IVD) Beckman Coulter Australia Pty Ltd Australia
Access Immunoassay Systems Access Folate Calibrators, An in vitro diagnostic medical device (IVD) Beckman Coulter Australia Pty Ltd Australia
cobas p 612 pre-analytical system (LCP1). An in vitro diagnostic medical device (IVD). Roche Diagnostics Australia Pty Limited Australia
Conveyor unit (CV-50) of Sysmex XN-9000 automated haematology analysers. An in vitro diagnostic medical device (IVD) Roche Diagnostics Australia Pty Limited Australia
Accu-Chek Inform II Test. An in vitro diagnostic medical device (IVD) Roche Diagnostics Australia Pty Limited Australia
cobas MPX test. An in vitro diagnostic medical device (IVD). Roche Diagnostics Australia Pty Limited Australia
Combur10 Test UX when measured on Urisys 1100. An in vitro diagnostic medical device (IVD) Roche Diagnostics Australia Pty Limited Australia
Cobas e 801 Analytical Unit. An in vitro diagnostic medical device. Roche Diagnostics Australia Pty Limited Australia
Hematoxylin II and Horseradish Peroxidase Reagents - An in vitro medical devices Roche Diagnostics Australia Pty Limited Australia
Fluorocell PLT reagent. An in vitro diagnostic medical device (IVD)(used on Sysmex XN-10 and XN-20 Automated Haematology Analysers) Roche Diagnostics Australia Pty Limited Australia
CoaguChek HS Plus/Pro System. An in vitro diagnostic medical device (IVD) Roche Diagnostics Australia Pty Limited Australia
cobas 8000 core unit with software versions 5.01 and later. An in vitro diagnostic medical device (IVD) Roche Diagnostics Australia Pty Limited Australia
Ultrasonic Mixer cover (USM) 3. An in vitro diagnostic medical device (IVD)(used with cobas c 501 and c502 modules) Roche Diagnostics Australia Pty Limited Australia
Various Immunochemistry modules. An in vitro diagnostic medical device (IVD)cobas e 601 module Clinical Chemistry and Clinical Toxicology Devices Roche Diagnostics Australia Pty Limited Australia
cobas e 411 analyser. An in vitro diagnostic medical device (IVD) Roche Diagnostics Australia Pty Limited Australia
Sysmex XN-450, XN-550 & other XN-L series Automated Haematology Analysers. An in vitro diagnostic medical device (IVD) Roche Diagnostics Australia Pty Limited Australia
cobas omni MGP Reagent when used with cobas MPX assay. An in vitro diagnostic medical device (IVD)(for use on the cobas 6800/8800 systems) Roche Diagnostics Australia Pty Limited Australia
cobas 4800 HPV Amplification/Detection Kit. An in vitro diagnostic medical device (IVD) Roche Diagnostics Australia Pty Limited Australia
Sysmex XN-10 and XN-20 Automated Haematology Analysers. An in vitro diagnostic medical device (IVD) Roche Diagnostics Australia Pty Limited Australia
Sysmex XN-550 Automated Haematology Analyser. An in vitro diagnostic medical device (IVD) Roche Diagnostics Australia Pty Limited Australia
Sample Probe Connector used with cobas modules. An in vitro diagnostic medical device (IVD) Roche Diagnostics Australia Pty Limited Australia
cobas 8000 modular analyser series. An in vitro diagnostic medical device (IVD) Roche Diagnostics Australia Pty Limited Australia