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

helena laboratories australia pty ltd - ct872 - coagulation calibrator/control ivds - ivds that are intended to be used in testing to establish known points of reference and/or verify the performance of coagulation assays.

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

helena laboratories australia pty ltd - 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)

helena laboratories australia pty ltd - ct943 - instrument/analyser ivds - instruments that are intended by the manufacturer to be used as an ivd for the purposes of processing, examining and/or providing information about a clinical specimen. these analysers are used to measure the activated clotting time (act) of a clinical specimen.

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

helena laboratories australia pty ltd - ct874 - platelet factor ivds - ivds that are intended to be used in testing to provide information about platelet factor components or platelet functionality.

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

helena laboratories australia pty ltd - ct872 - coagulation calibrator/control ivds - ivds that are intended to be used in testing to establish known points of reference and/or verify the performance of coagulation assays.

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

helena laboratories 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)

helena laboratories australia pty ltd - ct974 - clinical chemistry-specific protein ivds - ivds that are intended to be used for the qualitative and/or quantitative determination of proteins specific to clinical chemistry, in a clinical specimen.

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

helena laboratories australia pty ltd - ct880 - haemoglobin ivds - ivds that are intended to be used for the qualitative and/or quantitative determination of haemoglobin and the various subtypes of haemoglobin in a clinical specimen.

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

helena laboratories 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)

helena laboratories australia pty ltd - ct877 - coagulation factor ivds - ivds that are intended to be used for the qualitative and/or quantitative determination of individual clotting factors within the coagulation cascade.