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

werfen 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)

werfen australia pty ltd - ct875 - fibrinolysis ivds - ivds that are intended to be used in testing to provide information about fibrinolysis, fibrin degradation products and components involved in the process of clot breakdown.

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

werfen 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)

werfen australia pty ltd - ct799 - treponema (syphilis) ivds - ivds that are intended to be used in testing to provide information about infection with or exposure to treponema bacteria, the spirochete bacteria associated with syphilis.

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.

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

werfen australia pty ltd - ct355 - viral infectious disease ivds - ivds that are intended to be used in testing to provide information about infection with or exposure to epstein-barr virus (ebv), also referred to as human herpesvirus 4.

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

werfen australia pty ltd - ct945 - general laboratoryware ivds - laboratory ware such as general reagents, laboratory products, consumables, biological stains, antimicrobial identification tests and antimicrobial susceptibility tests that are intended to be used specifically as an ivd in the testing of clinical specimens within any discipline of a pathology laboratory.

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

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

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

werfen australia pty ltd - ct871 - general coagulation ivds - 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)

werfen australia pty ltd - ct943 - instrument/analyser ivds - equipment intended by the manufacturer to be used as an in vitro diagnostic medical device (ivd) for the purposes of processing, examining and/or providing information about a clinical specimen.