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

grifols australia pty ltd - immunoglobulin - normal; human normal immunoglobulin -

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

grifols australia pty ltd - immunoglobulin - normal; normal immunoglobulin (human); normal immunoglobulin (human) -

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

grifols australia pty ltd - ct944 - software ivds - blood typing manager is a transfusion data manager software that aids in interfacing and managing data between immunohematology instruments, blood establishment computer software and laboratory information system. blood typing manager can only be used with the grifols erytra, grifols erytra eflexis, grifols wadiana compact, grifols dg reader and grifols dg reader net instruments.

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

grifols australia pty ltd - normal immunoglobulin, quantity: 40 g - liquid, multipurpose - excipient ingredients: glycine; water for injections - gamunex normal immunoglobulin (human), 10% is a replacement therapy in: - primary imunodeficiency (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 barre syndrome (gbs). - chronic inflammatory demyelinating polyneuropathy (cidp),-kawasaki disease.

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

grifols australia pty ltd - ct943 - instrument/analyser ivds - manual, semi-automated or automated equipment or apparatus that are intended to be used as an in vitro diagnostic medical device for the purposes of processing, examining and/or providing information about a clinical specimen.

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

grifols australia pty ltd - ct943 - instrument/analyser ivds - manual, semi-automated or automated equipment or apparatus that are intended to be used as an in vitro diagnostic medical device for the purposes of processing, examining and/or providing information about a clinical specimen.

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

grifols australia pty ltd - 62052 - hiv1/hiv2/hepatitis c virus/hepatitis b virus nucleic acid ivd, kit, nucleic acid technique (nat) - the procleix ultrio elite assay is a qualitative in vitro nucleic acid amplification test for the detection of human immunodeficiency virus type 1 and human immunodeficiency virus type 2 (hiv) rna, hepatitis c virus (hcv) rna, and/or hepatitis b virus (hbv) dna in plasma and serum specimens from human donors, tested individually. it is also intended for use in testing plasma and serum to screen organ and tissue donors, including cadaveric (non-heartbeating) donors. the procleix ultrio elite assay is a qualitative in vitro nucleic acid amplification test for the detection of human immunodeficiency virus type 1 and human; immunodeficiency virus type 2 (hiv) rna, hepatitis c virus (hcv) rna, and/or hepatitis b virus (hbv) dna in plasma and serum specimens from human donors, including donors of whole blood, blood components, and source plasma, and from other living donors. it is also intended for use in testing plasma and serum to screen organ and tissue donors when specimens are obtained while the donor?s heart is still beating, and in testing blood specimens from cadaveric (non-heart-beating) donors. this assay is not intended for use on cord blood specimens. it is also intended for use in testing pools of human plasma composed of equal aliquots of not more than 16 individual specimens from donors of plasma fractionation which is further manufactured into plasma-derived products which include viral inactivation and removal procedures only. this assay is not intended for use as an aid in diagnosis.; note: this assay is not intended for detection of hiv-1, hiv-2, hcv, and hbv in pooled plasma and serum specimens from cadaveric (non-heartbeating) donors.

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

grifols australia pty ltd - 48216 - hiv1/hepatitis c virus/hepatitis b virus nucleic acid ivd, kit, nucleic acid technique (nat) - the procleix ultrio plus assay is a qualitative in vitro nucleic acid amplification test for the detection of human immunodeficiency virus type 1 (hiv-1) rna, hepatitis c virus (hcv) rna, and /or hepatitis b virus (hbv) dna in plasma and serum samples from human donors, tested individually. it is also intended for use in testing plasma and serum to screen orand and tissue donors, including cadaveric (non heart-beating) donors. it is not intended for use on samples of cord blood. the procleix ultrio plus assay is a qualitative in vitro nucleic acid amplification test for the detection of human immunodeficiency virus type 1 (hiv-1) rna, hepatitis c virus (hcv) rna, and /or hepatitis b virus (hbv) dna in plasma and serum samples from human donors, tested individually. it is also intended for use in testing plasma and serum to screen orand and tissue donors, including cadaveric (non heart-beating) donors. it is not intended for use on samples of cord blood. the assay is not intended for use as an aid in diagnosis

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

grifols australia pty ltd - ct945 - general laboratoryware ivds - procleix assay fluids (oil/wash solution/buffer for deactivation fluid)to be used with procleix assays; procleix system fluid preservative is a concentrate used to inhibit microbial growth in the system fluid bottle and hydraulic pipettor lines of the procleix tigris system; procleix auto detect reagents to be used with procleix assays.

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

grifols australia pty ltd - ct945 - general laboratoryware ivds - general reagents, laboratory products, consumables, biological stains, antimicrobial identification tests and antimicrobial susceptibility tests.