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

abacus dx pty ltd - ct944 - software ivds - software for operating an ivd instrument including the virclia lotus analyzers for in vitro chemiluminescence immunoassays. the software is installed on an accompanying pc/laptop.

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

abacus dx pty ltd - ct1236 - clinical chemistry biological screening ivds - controls intended to monitor the performance of multiple qualitative and/or quantitative assay methods used to detect the presence of a variety of components such as bilirubin, blood, cells, creatinine, crystals, glucose, ketone, leukocyte, microscopic components, nitrite, ph, proteins, sediment, specific gravity, urobilinogen, and other biological and chemical specimens.

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

abacus dx pty ltd - ct945 - general laboratoryware ivds - general reagents or laboratory-ware for use with ivds

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

abacus dx pty ltd - ct215 - biological stain ivds - biologic stains, including mcdh (micro chromatic detection for hematology) providing romanowsky-giemsa staining results, particularly visible in the chromatic platelets and neutrophilic granules for higher reproducibility and standardized cell morphology and reduced stain precipitation.

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

abacus dx pty ltd - ct943 - instrument/analyser ivds - automated programmable staining and staining support systems.

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

abacus dx pty ltd - ct943 - instrument/analyser ivds - real time pcr systems for scaling up research and high sample throughput in diagnostic lab applications

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

abacus dx pty ltd - ct833 - clinical chemistry substrate ivds - ivds used on the quikread go instrument for the qualitative and/or quantitative determination of clinical chemistry substrates in a clinical specimen, including hba1c for monitoring long term control of glucose from diabetes mellitus or as an aid in diagnosing diabetes. these assays and controls are intended to be used by trained healthcare professionals in clinical laboratories and/or near-patient/point-of-care testing settings.

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

abacus dx pty ltd - ct889 - multiple clinical chemistry constituent ivds - verification ivds use in the quantitative determination of linearity, calibration verification and verification of reportable range in automated, semi-automated and manual instrument systems for various analytes

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

abacus dx pty ltd - ct850 - clinical chemistry hormone ivds - hormone calibration verification and/or linearity test kits

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

abacus dx pty ltd - ct833 - clinical chemistry substrate ivds - calibration verification/linearity test kits for a range of clinical chemistry substrates