Australia - English - Department of Health (Therapeutic Goods Administration)

roche diagnostics australia pty limited - ct871 - general coagulation ivds - ivds that are intended to be used in testing to provide information about the general coagulation of blood and the time taken for a clinical blood specimen to clot following initiation of the intrinsic and/or extrinsic coagulation pathways

Australia - English - Department of Health (Therapeutic Goods Administration)

roche diagnostics australia pty limited - ct929 - acquired genetic alteration ivds - dna ivd probes intended to be used in genetic testing to provide information about acquired genetic alterations, which may include chromosomal alterations, mutations and/or alterations in gene expression, and which may be used to characterise haematological or solid tumour malignancies and/or provide prognostic information.

Australia - English - Department of Health (Therapeutic Goods Administration)

roche diagnostics australia pty limited - ct929 - acquired genetic alteration ivds - ivds that are intended to be used in genetic testing to provide information about acquired genetic alterations, which may include chromosomal alterations, mutations and/or alterations in gene expression, and which may be used to characterise haematological or solid tumour malignancies and/or provide prognostic information.

Australia - English - Department of Health (Therapeutic Goods Administration)

roche diagnostics australia pty limited - ct929 - acquired genetic alteration ivds - ivds that are intended to be used in genetic testing to provide information about acquired genetic alterations, which may include chromosomal alterations, mutations and/or alterations in gene expression, and which may be used to characterise haematological or solid tumour malignancies and/or provide prognostic information.

Australia - English - Department of Health (Therapeutic Goods Administration)

roche diagnostics australia pty limited - ct929 - acquired genetic alteration ivds - the ventana anti-her2/neu (4b5) rabbit monoclonal primary antibody (ventana her2 (4b5)) is intended for the semi-quantitative detection of her2 antigen in sections of formalin-fixed, paraffin-embedded normal and neoplastic breast and gastric tissue on a ventana automated slide staining device. it is indicated as an aid in the assessment of breast and gastric cancer patients for whom herceptin treatment is considered. the results of this test should be evaluated within the context of the patient?s clinical history and other diagnostic tests evaluated by a qualified pathologist. any staining performed in the end user?s lab should be interpreted within the context of the controls run with the clinical cases at the time of evaluation.

Australia - English - Department of Health (Therapeutic Goods Administration)

roche diagnostics australia pty limited - ct1250 - analyser software ivds - software used to supplement operational functions which may include the processing of specimens, generation of data, interpretation, storage, display and/or reporting of results obtained from a clinical laboratory specimen.

Australia - English - Department of Health (Therapeutic Goods Administration)

roche diagnostics australia pty limited - 48298 - hepatitis b virus core immunoglobulin m (igm) antibody ivd, kit, chemiluminescent immunoassay - ??capture test principle immunoassay: total duration of assay: 18 minutes. results are determined automatically by the software by comparing the electrochemiluminescence signal obtained from the reaction product of the sample with the signal of the cutoff value previously obtained by calibration. immunoassay and dedicated quality control for the in vitro qualitative determination of igm antibodies to the hepatitis b core antigen in human serum and plasma. this electrochemiluminescence (eclia) assay is intended for use on elecsys and cobas immunoassay analysers.

Australia - English - Department of Health (Therapeutic Goods Administration)

roche diagnostics australia pty limited - 48366 - hepatitis c virus total antibody ivd, kit, chemiluminescent assay - an electrochemiluminescence immunoassay "eclia" intended for use on the cobas e immunoassay analyzers for the in vitro qualitative detection of antibodies to hepatitis c virus (hcv). the anti-hcv ii is an in vitro diagnostic assay for the qualitative detection of antibodies to hepatitis c virus in serum and plasma. this electrochemiluminescence (eclia) assay is intended for use on elecsys and cobas immunoassay analysers

Australia - English - Department of Health (Therapeutic Goods Administration)

roche diagnostics australia pty limited - ct869 - clinical chemistry autoimmune ivds - assays used for the detection or determination of markers of autoimmunity in a biological sample

Australia - English - Department of Health (Therapeutic Goods Administration)

roche diagnostics australia pty limited - ct836 - clinical chemistry electrolyte ivds - products used to measure electrolyte and ion concentrations in biological samples