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

roche diagnostics australia pty limited - 48298 - hepatitis b virus core immunoglobulin m (igm) antibody ivd, kit, chemiluminescent immunoassay - ??capture test principle immunoassay: total duration of assay: 18 minutes. results are determined automatically by the software by comparing the electrochemiluminescence signal obtained from the reaction product of the sample with the signal of the cutoff value previously obtained by calibration. immunoassay and dedicated quality control for the in vitro qualitative determination of igm antibodies to the hepatitis b core antigen in human serum and plasma. this electrochemiluminescence (eclia) assay is intended for use on elecsys and cobas immunoassay analysers.

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

roche diagnostics australia pty limited - 48366 - hepatitis c virus total antibody ivd, kit, chemiluminescent assay - an electrochemiluminescence immunoassay "eclia" intended for use on the cobas e immunoassay analyzers for the in vitro qualitative detection of antibodies to hepatitis c virus (hcv). the anti-hcv ii is an in vitro diagnostic assay for the qualitative detection of antibodies to hepatitis c virus in serum and plasma. this electrochemiluminescence (eclia) assay is intended for use on elecsys and cobas immunoassay analysers

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

roche diagnostics australia pty limited - 60812 - hepatitis b virus surface antigen neutralization ivd, kit, chemiluminescent immunoassay - the elecsys hbsag confirmatory test is based on the principle of specific antibody neutralization. polyclonal hbsag-specific antibodies bind to the immunodominant epitopes of the hepatitis b surface antigen and thereby block the binding sites for the antibodies used in the assay. immunoassay for in vitro confirmation of the presence of hepatitis b surface antigen in human serum and plasma samples repeatedly reactive when tested with the elecsys hbsag ii assay. this electrochemiluminescence (eclia) assay is intended for use on elecsys and cobas immunoassay analysers.

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

roche diagnostics australia pty limited - 41973 - hepatitis c virus total antibody ivd, control - precicontrol anti?hcv is a ready?for?use control serum based on human serum both in the negative and positive concentration range. the controls are used for monitoring the accuracy of the elecsys anti?hcv and elecsys anti?hcv ii immunoassays. precicontrol anti?hcv is used for quality control of the anti?hcv and anti?hcv ii immunoassays on the elecsys and cobas e immunoassay analyzers.

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

roche diagnostics australia pty limited - 48446 - hiv1/hiv2 antigen/antibody ivd, kit, chemiluminescent immunoassay - immunoassay for the in vitro qualitative determination of hiv-1 p24 antigen and antibodies to hiv-1, including group o, and hiv-2 in human serum and plasma using the elecsys and cobas e analytical systems immunoassay for the in vitro qualitative determination of hiv-1 p24 antigen and antibodies to hiv-1, including group o, and hiv-2 in human serum and plasma using the elecsys and cobas e analytical systems

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

roche diagnostics australia pty limited - 49713 - cytomegalovirus (cmv) immunoglobulin g (igg) antibody ivd, kit, chemiluminescent immunoassay - an electrochemiluminescence immunoassay ?eclia? intended for use on elecsys and cobas e immunoassay analyzers for the in vitro quantitative determination of igg antibodies to cytomegalovirus. immunoassay for the in vitro quantitative determination of igg antibodies to cytomegalovirus in human serum and plasma, for diagnostic use and screening of blood donations.

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

roche diagnostics australia pty limited - 59863 - treponema pallidum total antibody ivd, kit, chemiluminescent immunoassay - an electrochemiluminescence immunoassay ?eclia? intended for use on the elecsys and cobas e immunoassay analyzers for the in vitro qualitative determination of total antibodies to treponema pallidum. immunoassay for the in vitro qualitative determination of total antibodies to treponema pallidum in human serum and plasma, for diagnostic use and screening of blood donations.

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

roche diagnostics australia pty limited - 60812 - hepatitis b virus surface antigen neutralization ivd, kit, chemiluminescent immunoassay - the elecsys hbsag ii auto confirm assay is a fully automated confirmatory assay, based on the principle of specific antibody neutralization, intended to be used for samples repeatedly reactive in the elecsys hbsag ii assay. polyclonal hbsag specific antibodies bind to the immunodominant epitopes of hbsag and thereby block the binding sites for the antibodies used in the elecsys hbsag ii assay. immunoassay and control for in vitro confirmation of the presence of hepatitis b surface antigen in human serum and plasma samples repeatedly reactive when tested with the elecsys hbsag ii assay. these electrochemiluminescence immunoassays (eclia) are intended for use on cobas e immunoassay analysers.

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

roche diagnostics australia pty limited - 48382 - hepatitis c virus antibody/antigen ivd, kit, chemiluminescent immunoassay - elecsys hcv duo is an electrochemiluminescence immunoassay for the in vitro qualitative detection of hepatitis c virus (hcv) core antigen (hcv ag) and antibodies to hcv (anti-hcv) in human serum and plasma. elecsys hcv duo is an immunoassay for the in vitro qualitative detection of hepatitis c virus (hcv) core antigen (hcv ag) and antibodies to hcv (anti-hcv) in human serum and plasma. the test in conjunction with other laboratory results and clinical information, may be used to aid in the diagnosis of and the screening of hcv infection. the test can also be used as a screening test to prevent transmission of hcv to recipients of blood, blood components, cells, tissue, and organs. the subresults (hcv ag and anti-hcv) are intended as an aid in the selection of the confirmatory testing algorithm for reactive samples.the electrochemiluminescence immunoassay ?eclia? is intended for use on cobas e immunoassay analyzers.

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

roche diagnostics australia pty limited - 48321 - hepatitis b virus surface antigen ivd, kit, chemiluminescent immunoassay - an electrochemiluminescence immunoassay "eclia" intended for use on the cobas e immunoassay analyzers. immunoassay for the in vitro qualitative determination of hepatitis b surface antigen (hbsag) in human serum and plasma, for diagnostic use, screening of blood donations.