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

boston scientific pty ltd - 59026 - ultrasound thrombolysis system catheter - intended for controlled and selective infusion of physician specified fluids, including thrombolytics into the peripheral vasculature.

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

boston scientific pty ltd - 59025 - ultrasound thrombolysis system control unit - the ekos control unit is intended exclusively for use with the ekosonic endovascular infusion catheters to generates high frequency, low energy ultrasound for thrombolytic drug administration. the ultrasound prepares the clot by unwinding the fibrin strands enabling increased drug permeation through the clot to the vessel wall.

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

pm separations pty ltd - ct881 - red and white cell metabolic enzyme and haemolysis ivds - for the quantitative, kinetic determination of glucose-6-phosphate dehydrogenase (g6pd) in blood at 340 nm. for in vitro diagnostic use only.

New Zealand - Inggeris - Ministry for Primary Industries

schering-plough animal health limited - dichelobacter nodosus - dichelobacter nodosus 0 vaccine - vaccine

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

abacus dx pty ltd - ct881 - red and white cell metabolic enzyme and haemolysis ivds - intended use - the carestart g6pd test is a rapid in vitro qualitative detection test for g6pd enzyme activity in human blood samples. this visual screening assay detects samples of deficient g6pd activity and is intended to aid in the diagnosis of individuals who are g6pd deficient.

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

mindray medical australia pty ltd - ct881 - red and white cell metabolic enzyme and haemolysis ivds - a substance or reactant intended to be used together with a parent ivd to perform a specific function in an assay that is used for quantitative determination of g6pd in human erythrocytes on photometric systems.

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

immuno pty ltd - ct881 - red and white cell metabolic enzyme and haemolysis ivds - ivds that are intended to be used for the qualitative and/or quantitative determination of white and red cell metabolic enzymes and cellular membrane integrity in a clinical specimen.

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

siemens healthcare pty ltd - ct881 - red and white cell metabolic enzyme and haemolysis ivds - kinetic determination of enzymes in red and white blood cell.

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

boston scientific pty ltd - 59025 - ultrasound thrombolysis system control unit - the control system is intended for use with the endovascular devices to employ high frequency, low power ultrasound to facilitate the infusion of physician-specified fluids, including procedural fluids and thrombolytics, into the pulmonary and/or peripheral vasculature of adults.

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

boston scientific pty ltd - 59223 - ultrasound thrombolysis system pulmonary artery catheter - the system generates ultrasonic energy waves at the treatment zone through the piezoelectric transduction of radio-frequency (rf) energy generated by the control unit. the ultrasound emanates radially from the treatment zone into and through blood, thrombus, or tissue surrounding the treatment zone, within the patient?s vasculature. the ultrasound acts locally to increase the dispersion of the delivered physician specified fluids into the treatment region. the ekos endovascular device is intended to be used with ekos-branded control systems to employ high frequency (2 mhz -3 mhz), low power ultrasound to facilitate the infusion of physician-specified fluids, including procedural fluids and thrombolytics, into the pulmonary and/or peripheral vasculature of adults. it is intended to be used by physicians with knowledge in endovascular interventional procedures. the ekos endovascular system is not intended for use in the neurovasculature. the intended patient population is considered adult patients with symptomatic thrombosis in the pulmonary vessels and/or in the peripheral vasculature such as the iliac and femoral vessels.