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

diasorin australia pty ltd - 59863 - treponema pallidum total antibody ivd, kit, chemiluminescent immunoassay - the method for determination of specific total antibodies to treponema pallidum is a one-step sandwich chemiluminescence immunoassay (clia). the liaison? treponema screen assay uses chemiluminescent immunoassay (clia) technology for the qualitative determination of specific total antibodies to treponema pallidum in human serum or plasma samples including post-mortem specimens, collected up to 24 hours after death. the test has to be performed on the liaison? analyzer family.

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

diasorin australia pty ltd - 48365 - hepatitis c virus total antibody ivd, kit, enzyme immunoassay (eia) - murex anti-hcv (version 4.0) is an enzyme immunoassay for the detection of antibodies to hepatitis c virus (hcv) in human serum or plasma. ivds that are intended to be used in testing to provide information about infection with or exposure to hepatitis c virus.

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)

diasorin australia pty ltd - ct910 - interpretive software ivds - software intended to analyze data generated by liaison? analyzers.

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

diasorin australia pty ltd - ct791 - mycobacteria ivds - ivds that are intended to be used as an aid in the diagnosis of m. tuberculosis infection.

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

diasorin australia pty ltd - ct772 - severe acute respiratory syndrome-associated coronavirus ivds - ivds intended for the in vitro qualitative detection of severe acute respiratory syndrome coronavirus 2 (sars-cov-2) viral rna.

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

diasorin australia pty ltd - ct772 - severe acute respiratory syndrome-associated coronavirus ivds - ivds that use chemiluminescence immunoassay (clia) technology for the determination of specific antibodies to sars-cov-2 in human serum or plasma.

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

diasorin australia pty ltd - ct707 - hepatitis e virus ivds - ivds that use chemiluminescence immunoassay (clia) technology for the determination of specific antibodies to hepatitis e virus in human serum or plasma. ivds intended as an aid in the diagnosis of hev infection in individuals with or without symptoms of hepatitis.

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

diasorin australia pty ltd - ct756 - varicella zoster virus (human herpesvirus 3) ivds - for the in vitro qualitative detection of varicella zoster virus (vzv) viral dna present in cerebrospinal fluid, or in cutaneous and mucocutaneous lession swabs from patients with signs and symptoms of vzv infection. for use as an aid in the diagnosis of vzv infection of the cns and, where applicable, in the differential diagnosis of vzv infection.

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

diasorin australia pty ltd - ct353 - bacterial infectious disease ivds - for the in vitro qualitative detection of bacteria present in samples from human individuals suspected of a bacterial infection. for use on the integrated cycler instrument.