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

beckman coulter australia pty ltd - 48304 - hepatitis b virus core total antibody ivd, kit, chemiluminescent immunoassay - qualitative immunoassay integrated to the access immunoassay systems, for the detection of antibodies directed against hepatitis b core antigen in human serum or plasma the access hbc ab assay is a qualitative immunoassay integrated to the access immunoassay systems, for the detection of antibodies directed against hepatitis b core antigen in human serum or plasma.

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

beckman coulter australia pty ltd - 48298 - hepatitis b virus core immunoglobulin m (igm) antibody ivd, kit, chemiluminescent immunoassay - paramagnetic-particle, chemiluminescent immunoassay for the detection of igm antibody to core antigen of hepatitis b virus in human serum and plasma using the access immunoassay systems. the access hbc igm assay is a paramagnetic-particle, chemiluminescent immunoassay for the detection of igm antibody to core antigen of hepatitis b virus in human serum and plasma using the access immunoassay systems.

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

beckman coulter australia pty ltd - ct943 - instrument/analyser ivds - manual, semi-automated equipment or apparatus that are 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.

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

beckman coulter 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)

beckman coulter australia pty ltd - ct946 - general laboratory reagent and consumables ivds - ivds that are general laboratory reagents, products or consumables, that are intended to be used specifically as an ivd in the testing of specimens within a clinical laboratory.

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

beckman coulter 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)

beckman coulter 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 (e.g. tissue processing solutions, resins, enhancing reagents).

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

beckman coulter australia pty ltd - ct946 - general laboratory reagent and consumables ivds - ivds that are general laboratory reagents, products or consumables, that are intended to be used specifically as an ivd in the testing of specimens within a clinical laboratory.

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

beckman coulter australia pty ltd - ct945 - general laboratoryware ivds - general reagents, laboratory products, consumables, biological stains that are intended to be used specifically as an ivd in the testing of clinical specimens.

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

beckman coulter 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.