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

siemens healthcare pty ltd - 48360 - hepatitis c virus immunoglobulin g (igg) antibody ivd, kit, chemiluminescent immunoassay - advia centaur hcv is an indirect two wash sandwich immunoassay used for the detection of igg antibody to hepatitis c virus (hcv) in human serum or plasma. an in vitro diagnostic immunoassay for the qualitative determination of igg antibodies to hepatitis c virus (hcv) in clinical specimens. this ivd may be used in conjunction with other serological and clinical information to aid in the diagnosis of individuals with symptoms of hepatitis and in individuals at risk for hepatitis c infection.

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

abbott australasia pty ltd diagnostic division - 48316 - hepatitis b virus surface total antibody ivd, kit, chemiluminescent immunoassay - this assay is a two-step immunoassay for the quantitative determination of anti-hbs in human serum and plasma using chemiluminescent microparticle immunoassay (cmia) technology. the alinity i anti-hbs assay is a chemiluminescent microparticle immunoassay (cmia) used for the quantitative determination of antibody to hepatitis b surface antigen (anti-hbs) in human serum and plasma on the alinity i analyzer.

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)

diasorin australia pty ltd - 48316 - hepatitis b virus surface total antibody ivd, kit, chemiluminescent immunoassay - the liaison? xl murex anti-hbs assay uses chemiluminescence immunoassay (clia) technology for the quantitative determination of antibody to hepatitis b surface antigen (anti-hbs) in human serum or plasma samples. the test has to be performed on the liaison? analyzer family. ivds for the quantitative determination of antibody to hepatitis b surface antigen (anti-hbs).

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

siemens healthcare pty ltd - 48360 - hepatitis c virus immunoglobulin g (igg) antibody ivd, kit, chemiluminescent immunoassay - atellica im ahcv assay is an indirect 2-wash sandwich immunoassay used for the detection of igg antibody to hepatitis c virus (hcv) in human serum or plasma. an in vitro diagnostic immunoassay for the qualitative determination of igg antibodies to hepatitis c virus (hcv) in human serum and plasma (edta, lithium heparin, and sodium heparin). this ivd may be used in conjunction with other serological and clinical information to aid in the diagnosis of individuals with symptoms of hepatitis and in individuals at risk for hepatitis c infection.

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

siemens healthcare pty ltd - 48316 - hepatitis b virus surface total antibody ivd, kit, chemiluminescent immunoassay - the atellica im ahbs2 assay is an antibody-capture microparticle direct chemiluminescent immunoassay used to measure the amount of antibody to hepatitis surface antigen in human serum and plasma. an in vitro diagnostic immunoassay for the qualitative and quantitative determination of total antibodies to hepatitis b surface antigen in human serum and plasma (edta and heparin). the assay results may be used as an aid in the determination of susceptibility to hepatitis b virus (hbv) infection in individuals prior to or following hbv vaccination or where vaccination status is unknown. assay results may be used with other hbv serological markers for the laboratory diagnosis of hbv disease associated with hbv infection. a reactive assay result will allow a differential diagnosis in individuals displaying signs and symptoms of hepatitis in whom etiology is unknown.

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

siemens healthcare pty ltd - 48304 - hepatitis b virus core total antibody ivd, kit, chemiluminescent immunoassay - the atellica im hbct assay is a 2-wash antigen sandwich immunoassay in which antigens are bridged by antibody present in the patient sample. an in vitro diagnostic immunoassay for the qualitative determination of total antibodies to the core antigen of the hepatitis b virus in human serum and edta plasma. this assay can be used as an aid in the diagnosis of individuals with acute or chronic hepatitis b virus (hbv) infection and in the determination of the clinical status of hbv-infected individuals in conjunction with other hbv serological markers for the laboratory diagnosis of hbv disease associated with hbv infection. this assay can also be used as an aid in the differential diagnosis in individuals displaying signs and symptoms of hepatitis in whom etiology is unknown.