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

werfen australia pty ltd - ct943 - instrument/analyser ivds - an in vitro diagnostic instrument for use by health care professionals in a clinical setting and in a central laboratory for the purposes of quantitative measurements of whole blood samples.

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

werfen australia pty ltd - ct943 - instrument/analyser ivds - automated immunoassay analysers designed for in vitro diagnostic use in a clinical laboratory.

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

werfen australia pty ltd - ct943 - instrument/analyser ivds - instrument/analyser ivds for processing, examining and/or providing information about a clinical speciman.

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

werfen australia pty ltd - ct771 - rubella virus ivds - fully automated chemiluminescent two step immunoassay intended to be used for the quantitative measurement of antibodies in human serum or plasma to provide information about infection with or exposure to rubella virus.

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

werfen australia pty ltd - ct876 - thrombophilia and coagulation inhibitor ivds - ivds that are intended to be used in testing to provide information about thrombosis or the abnormal development of clots, and inhibitors of the coagulation process.

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

werfen australia pty ltd - ct820 - toxoplasma ivds - fully automated chemiluminescent two step immunoassay intended to be used for the quantitative measurement of antibodies in human serum or plasma to provide information about infection with the parasitic protozoan toxoplasma.

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

werfen australia pty ltd - ct889 - multiple clinical chemistry constituent ivds - ivds that are intended to be used for the qualitative and/or quantitative determination of multiple analytes (chemical, biological, and/or immunological) from more than one chemical specialty, in a clinical specimen.

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

werfen australia pty ltd - ct879 - haematology calibrator/control ivds - ivds that are intended to be used in testing to establish known points of reference and/or verify the performance of haematological assays.

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

werfen australia pty ltd - ct1248 - coagulation-related ivds - ivds that are intended to be used alone or in combination with other ivds to perform various coagulation-related tests and procedures.

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

werfen australia pty ltd - ct869 - clinical chemistry autoimmune ivds - ivds that are intended to be used for the qualitative and/or quantitative determination of autoimmune markers in a clinical specimen.