Devices

Name Classification Manufacturer Risk Class Country Source
Xpert CT/NG Assay. An in vitro diagnostic medical device (IVD) Cepheid Holdings Pty Ltd Australia
Xpert BCR-ABL Monitor assay (used for monitoring patients being treated for chronic myelogenous leukaemia). An in vitro diagnostic medical device (IVD). Cepheid Holdings Pty Ltd Australia
Xpert MRSA/SA Blood Culture Assay. An in vitro diagnostic medical device (IVD). Cepheid Holdings Pty Ltd Australia
Xpert HIV-1 Viral Load Assay. An in vitro diagnostic medical device (IVD). Cepheid Holdings Pty Ltd Australia
EZ-Strip 145ìm (Assisted reproduction microtool) Key IVF Supplies Australia
Feather Touch Vinyl Examination Gloves Pro-Pac Packaging Aust Pty Ltd Australia
TBS iNsight v. 3.0.1 (software installed on bone densitometers for estimating fracture risk) Inovanz Pty Ltd Australia
VITROS Chemistry Products Na+ Slides. An in vitro diagnostic medical device (IVD) Ortho-Clinical Diagnostics Australia Pty Ltd Australia
VITROS Chemistry Products PHYT Slides. An in vitro diagnostic medical device (IVD). Ortho-Clinical Diagnostics Australia Pty Ltd Australia
VITROS Immunodiagnostic Products Signal Reagent. An in vitro diagnostic medical device (IVD) Ortho-Clinical Diagnostics Australia Pty Ltd Australia
VITROS Performance Verifier II. An in vitro diagnostic medical device (IVD) Ortho-Clinical Diagnostics Australia Pty Ltd Australia
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
VITROS Immunodiagnostic Products NT-proBNP Reagent Pack. An in vitro diagnostic medical device (IVD) Ortho-Clinical Diagnostics Australia Pty Ltd Australia
VITROS Chemistry Products VANC Reagent. An in vitro diagnostic medical device (IVD). Ortho-Clinical Diagnostics Australia Pty Ltd Australia
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
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
Reagent Red Blood Cells 0.8% Resolve Panel C. An in vitro diagnostic medical device (IVD). Ortho-Clinical Diagnostics Australia Pty Ltd Australia
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
VITROS Chemistry Products C-reactive protein (CRP) Slides Ortho-Clinical Diagnostics Australia Pty Ltd Australia
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
Dynabeads HLA Class II and Dynabeads HLA Cell Prep II. An in vitro diagnostic medical device (IVD) Bio-Strategy Pty Ltd Australia
Prosigna Breast Cancer Prognostic Gene Signature Assay. An in vitro diagnostic medical device (IVD) Bio-Strategy Pty Ltd Australia
LABType DNA Typing Tests (for transplant compatibility analysis). An in vitro diagnostic medical device (IVD). Bio-Strategy Pty Ltd Australia
Charcot Osteotome Chisels Zimmer Biomet Pty Ltd Australia
Dermatome AN Zimmer Biomet Pty Ltd Australia