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

acra regulatory services pty ltd - ct860 - clinical chemistry therapeutic drug monitoring ivds - ivds that are intended for the in vitro quantitative measurement of busulfan in human heparinized plasma using automated clinical chemistry analysers. measurements obtained can be used to aid in management of individuals prescribed intravenous busulfan

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

beckman coulter australia pty ltd - ct869 - clinical chemistry autoimmune ivds - the rf latex calibrator is a liquid human serum based matrix calibrator intended to be used with the rf latex reagent osr61105 for the quantitative determination of rheumatoid factor on beckman coulter analysers. clinical chemistry autoimmune ivds

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

beckman coulter australia pty ltd - ct833 - clinical chemistry substrate ivds - clinical chemistry reagent/substrate, when used in conjunction with beckman coulter analysers, calibrators and controls, is intended for the quantitative determination of various analyte concentrations in human plasma, urine and cerebrospinal fluid (csf).

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

life bioscience pty ltd - ct833 - clinical chemistry substrate ivds - clinical chemistry substrate reagent packs for use by health professionals, on a specifically designed small point of care biochemistry analyser from the same manufacturer.

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

wincot pty ltd - ct833 - clinical chemistry substrate ivds - the easymate multi-function monitoring system is a clinical chemistry reagent/substrate, used in conjunction with the easymate analysers, calibrators and controls for the measurement of blood glucose. uric acid, cholesterol and haemoglobin in human capillary blood. this system is used for home-use and point-of-care environments.

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

pharmaco australia ltd - ct833 - clinical chemistry substrate ivds - reagent cartridge and control solutions for use with a poct hba1c analyser.

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

abacus dx pty ltd - ct1236 - clinical chemistry biological screening ivds - third party qc controls for testing a urine analysers ability to qualitatively and quantitatively screen urine for chemical, cellular and other components.

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

radiometer pacific pty ltd - ct833 - clinical chemistry substrate ivds - hemocue glucose microcuvettes are to be used in conjunction with the specified glucose analyser. the two combined are an ivd intended for the quantitative determination of glucose in a clinical specimen.

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

ortho-clinical diagnostics australia pty ltd - ct850 - clinical chemistry hormone ivds - ivds that are intended to be used for the qualitative and/or quantitative determination of clinical chemistry hormones in a clinical specimen.

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

ortho-clinical diagnostics australia pty ltd - ct847 - clinical chemistry vitamin and mineral ivds - ivds that are intended to be used for the qualitative and/or quantitative determination of vitamins and minerals in a clinical specimen.