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

abbott australasia pty ltd diagnostic division - 48524 - human t-cell lymphotrophic virus 1 & 2 (htlv1 & htlv2) antibody ivd, kit, chemiluminescent immunoassay - this assay is a two-step immunoassay for the qualitative detection of antibodies to htlv i and htlv ii in human serum and plasma using chemiluminescent microparticle immunoassay (cmia) technology. the alinity s htlv i/ii assay is a chemiluminescent microparticle immunoassay (cmia) used for the qualitative detection of antibodies to human t-lymphotropic virus type i and human t-lymphotropic virus type ii (anti-htlv i/htlv ii) in human serum and plasma, including specimens collected up to 24 hours postmortem (non-heart-beating), on the alinity s system.

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

abbott australasia pty ltd diagnostic division - 59861 - treponema pallidum immunoglobulin g (igg)/igm antibody ivd, kit, chemiluminescent immunoassay - this assay is a two-step immunoassay for the qualitative detection of antibody to tp in human serum or plasma using chemiluminescent microparticle immunoassay (cmia) technology. the alinity i syphilis tp assay is a chemiluminescent microparticle immunoassay (cmia) used for the qualitative detection of antibodies to treponema pallidum (tp) in human serum and plasma, including specimens collected post mortem (non-heart-beating)on the alinity i analyzer. performance has been established for the use of cadaveric blood specimens (specimens collected post-mortem, non-heart beating) that have been collected up to 24 hours after death.

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

abbott australasia pty ltd diagnostic division - 48304 - hepatitis b virus core total antibody ivd, kit, chemiluminescent immunoassay - the alinity i anti-hbc ii assay utilizes microparticles coated with recombinant hepatitis b virus core antigen (rhbcag) for the detection of anti-hbc. tthe alinity i anti-hbc ii assay is a chemiluminescent microparticle immunoassay (cmia) used for the qualitative detection of antibody to hepatitis b core antigen (anti-hbc) in human serum and plasma, including specimens collected post-mortem (non-heart beating) on the alinity i analyzer. performance has been established for the use of cadaveric blood specimens (specimens collected post-mortem, non-heartbeating) that have been collected up to 24 hours after death.

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

abbott australasia pty ltd diagnostic division - 48298 - hepatitis b virus core immunoglobulin m (igm) antibody ivd, kit, chemiluminescent immunoassay - the alinity i anti-hbc igm assay utilizes acridinium-labeled recombinant hepatitis b virus core antigen (rhbcag) conjugate for the detection of anti-hbc igm. the alinity i anti-hbc igm assay is a chemiluminescent microparticle immunoassay (cmia) used for the qualitative detection of igm antibody to hepatitis b core antigen (anti-hbc igm) in human serum and plasma on the alinity i analyzer. the alinity i anti-hbc igm assay is indicated for use as an aid in the diagnosis of acute or recent hepatitis b viral infection.

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

abbott australasia pty ltd diagnostic division - 48366 - hepatitis c virus total antibody ivd, kit, chemiluminescent assay - the alinity i anti-hcv assay is for the detection of antibodies to hepatitis c virus (hcv). chemiluminescent immunoassays are a variation of the enzyme immunoassay (eia) principle. the alinity i anti-hcv assay is a chemiluminescent microparticle immunoassay (cmia) used for the qualitative detection of antibody to hepatitis c virus (anti-hcv) in human serum and plasma, including specimens collected post mortem (non-heart beating) on the alinity i analyzer. performance has been established for the use of cadaveric blood specimens (specimens collected post-mortem, non-heartbeating) that have been collected up to 24 hours after death.

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

abbott australasia pty ltd diagnostic division - 48524 - human t-cell lymphotrophic virus 1 & 2 (htlv1 & htlv2) antibody ivd, kit, chemiluminescent immunoassay - this assay is a two-step immunoassay for the qualitative detection of antibodies to htlv-i and htlv-ii in human serum and plasma using chemiluminescent microparticle immunoassay (cmia) technology. the alinity i rhtlv-i/ii assay is a chemiluminescent microparticle immunoassay (cmia) used for the qualitative detection of antibodies to htlv-i and htlv-ii in human serum and plasma including specimens collected post-mortem (non-heart-beating) on the alinity i analyzer. performance has been established for the use of cadaveric blood specimens (specimens collected post-mortem, non-heartbeating) that have been collected up to 24 hours after death.

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

abbott australasia pty ltd diagnostic division - 48446 - hiv1/hiv2 antigen/antibody ivd, kit, chemiluminescent immunoassay - this assay is a two-step immunoassay for the qualitative detection of hiv p24 antigen and antibodies to hiv-1 (group m and group o), and hiv-2 in human serum or plasma using chemiluminescent microparticle immunoassay (cmia) technology. the alinity i hiv ag/ab combo assay is a chemiluminescent microparticle immunoassay (cmia) used for the simultaneous qualitative detection of hiv p24 antigen and antibodies to human immunodeficiency virus type 1 and/or type 2 (hiv-1/hiv-2) in human serum or plasma including specimens collected post mortem (non-heartbeating) on the alinity i analyzer. performance has been established for the use of cadaveric blood specimens (specimens collected post-mortem, non-heart beating) that have been collected up to 24 hours after death.

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

abbott australasia pty ltd diagnostic division - ct215 - biological stain ivds - dyes, chemicals, stains or solutions that are intended to be used specifically as an ivd, either alone or in combination with others,for the visualisation of structures and/or other intra/extracellular elements in biological tissues.

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

abbott australasia pty ltd diagnostic division - ct907 - histology and cytology ancillary ivds - ivds that are intended to be used alone or in combination with other ivds to perform various histology and cytology-related tests and procedures

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

abbott australasia pty ltd diagnostic division - ct944 - software ivds - software for the collection, input, storage, retrieval, interpretation or reporting of digital data or other information