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

grifols australia pty ltd - ct890 - immunohaematology calibrator/control ivds - immunohematology calibrators are intended to allow regular control of materials, work procedures and instrument procedures for (i) the determination of the abo, rhesus and k antigens, (ii) the determination of the appropriate abo blood group antibodies and (iii) the detection of irregular antibodies in both antiglobulin and enzyme technique. the product is suitable for use with dg gel technique, mdmulticard and conventional tube technique immunohematology calibrator are intended to allow regular control of materials, work procedures and instrument procedures for (i) the determination of the abo, rhesus and k antigens, (ii) the determination of the appropriate abo blood group antibodies and (iii) the detection of irregular antibodies in both antiglobulin and enzyme technique. the product is suitable for use with dg gel technique, mdmulticard and conventional tube technique.

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

grifols australia pty ltd - 43324 - fluid transfer set, general-purpose - disposable fluid transfer sets intended for the dosage/preparation of solutions using the gri-fill system.

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

grifols australia pty ltd - 35127 - intravenous fluid container, single use - gri-bags are disposable bags intended for solution dosage using the gri-fill system.

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

grifols australia pty ltd - ct887 - immunohaematology blood grouping antisera ivds - anti-lea for dg gel and anti-leb for dg gel are monoclonal antisera for gel technique to identify the lea and leb antigen on erythrocytes. the lewis antigens, lea and leb, are glycosphingolipids present in saliva and plasma. erythrocytes acquire their lewis phenotype by adsorbing lewis antigens from plasma. anti-p1 mono-type? dual is a monoclonal antiserum for tube test and gel technique to identify the p1 antigen on erythrocytes. of the three phenotypes p1, p2 and p (tja-) in the p system, p1 is mostly looked for. due to the varying strength of reactions, the p1 antigen may be graduated as p1 strong, p1 medium and p1 weak although these divisions of strength are more arbitrary than based on any demonstrable quantitative or qualitative differences.

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

grifols australia pty ltd - ct1250 - analyser software ivds - collects data from procleix systems to track individual donor samples and link them to appropriate test results. it collates results, assigns outcomes to individual samples, and formats output files. it can verify that master pool tubes have the required mass. it produces summary reports. it is used by personnel who are trained in its operation. retesting, reflex testing, worklist population, and export of final results can all be controlled. it manages test results for the procleix systems.

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

grifols australia pty ltd - normal immunoglobulin, quantity: 10 mg/ml - injection - excipient ingredients: glycine; water for injections - replacement therapy in: - primary immunodeficiency (pi) diseases; - symptomatic hypogammaglobulinaemia secondary to underlying disease or treatment. immunomodulation in: - idiopathic thrombocytopaenic purpura (itp), in patients at high risk of bleeding or prior to surgery to correct the platelet count; - guillain barr? syndrome (gbs); - chronic inflammatory demyelinating polyneuropathy (cidp); - kawasaki disease.

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

grifols australia pty ltd - normal immunoglobulin, quantity: 10 mg/ml - injection - excipient ingredients: water for injections; glycine - replacement therapy in: - primary immunodeficiency (pi) diseases; - symptomatic hypogammaglobulinaemia secondary to underlying disease or treatment. immunomodulation in: - idiopathic thrombocytopaenic purpura (itp), in patients at high risk of bleeding or prior to surgery to correct the platelet count; - guillain barr? syndrome (gbs); - chronic inflammatory demyelinating polyneuropathy (cidp); - kawasaki disease.

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

grifols australia pty ltd - normal immunoglobulin, quantity: 10 mg/ml - injection - excipient ingredients: glycine; water for injections - replacement therapy in: - primary immunodeficiency (pi) diseases; - symptomatic hypogammaglobulinaemia secondary to underlying disease or treatment. immunomodulation in: - idiopathic thrombocytopaenic purpura (itp), in patients at high risk of bleeding or prior to surgery to correct the platelet count; - guillain barr? syndrome (gbs); - chronic inflammatory demyelinating polyneuropathy (cidp); - kawasaki disease.

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

grifols australia pty ltd - normal immunoglobulin, quantity: 10 mg/ml - injection - excipient ingredients: water for injections; glycine - replacement therapy in: - primary immunodeficiency (pi) diseases; - symptomatic hypogammaglobulinaemia secondary to underlying disease or treatment. immunomodulation in: - idiopathic thrombocytopaenic purpura (itp), in patients at high risk of bleeding or prior to surgery to correct the platelet count; - guillain barr? syndrome (gbs); - chronic inflammatory demyelinating polyneuropathy (cidp); - kawasaki disease.

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

grifols australia pty ltd - normal immunoglobulin, quantity: 10 mg/ml - injection - excipient ingredients: glycine; water for injections - replacement therapy in: - primary immunodeficiency (pi) diseases; - symptomatic hypogammaglobulinaemia secondary to underlying disease or treatment. immunomodulation in: - idiopathic thrombocytopaenic purpura (itp), in patients at high risk of bleeding or prior to surgery to correct the platelet count; - guillain barr? syndrome (gbs); - chronic inflammatory demyelinating polyneuropathy (cidp); - kawasaki disease.