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

elitechgroup 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)

elitechgroup 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)

elitechgroup australia pty ltd - ct907 - histology and cytology ancillary ivds - ivds that are intended to be used alone or in combination with other ivds to perform various histology and cytology-related tests and procedures

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

elitechgroup australia pty ltd - ct1056 - immunohistology cell marker ivds - ivds that are intended to be used in histology and cytology to provide information about the presence and localisation of specific proteins and antigens present in histological tissue sections, cytological smears and fluids

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

elitechgroup australia pty ltd - ct923 - multiple infectious organism ivds - ivds that are intended to be used in testing to provide information about mixed infection with or exposure to multiple specified infectious organisms from different microbial groups.

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

elitechgroup 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)

elitechgroup australia pty ltd - ct878 - haematology full blood count ivds - ivd intended to be used for the quantitative haematological determination of measured and/or calculated whole blood cell parameters. full blood count, platelet, red blood cell count, reticulocyte count, white blood cell count.

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

elitechgroup australia pty ltd - ct943 - instrument/analyser ivds - automated instrument intended by the manufacturer to be used as an in vitro diagnostic medical device (ivd) for the purposes of providing a blood count on human blood specimens.

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

elitechgroup australia pty ltd - ct943 - instrument/analyser ivds - automated instruments used to process strip hybridization assays

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

elitechgroup australia pty ltd - ct903 - inborn/inherited genetic disorder ivds - devices intended to be used in screening/confirmation of congenital/inherited disorders.