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

roche diagnostics australia pty limited - 48446 - hiv1/hiv2 antigen/antibody ivd, kit, chemiluminescent immunoassay - an electrochemiluminescence immunoassay ?eclia? intended for use on the cobas e immunoassay analysers, 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. 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

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

ortho-clinical diagnostics australia pty ltd - 48446 - hiv1/hiv2 antigen/antibody ivd, kit, chemiluminescent immunoassay - vitros immunodiagnostic products hiv combo for the simultaneous qualitative detection of antibodies to human immunodeficiency virus types 1, including group m and o, and/or 2 (anti-hiv-1 and anti-hiv-2) and hiv p24 antigen in human serum and plasma (heparin and edta) in adults,pregnant women, adolescents and children, vitros immunodiagnostic products hiv combo reagent pack and calibrator for the simultaneous qualitative detection of antibodies to human immunodeficiency virus types 1, including group m and o, and/or 2 (anti-hiv-1 and anti-hiv-2) and hiv p24 antigen in human serum and plasma.

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

bio-rad laboratories pty ltd - 48446 - hiv1/hiv2 antigen/antibody ivd, kit, chemiluminescent immunoassay - the access hiv combo v2 assay is an immunoenzymatic assay based on the sandwich principle. the access hiv combo v2 assay is a paramagnetic-particle, semi-quantitative chemiluminescent immunoassay (clia) for the detection of hiv-1 p24 and hiv-2 p26 antigens and antibodies to hiv-1 and hiv-2 in human serum or plasma using the access immunoassay systems. this assay is intended to be used as an aid in the diagnosis of hiv infection and as a screening tool for blood and plasma donors. intended use: semi-quantitative immunoassay for the detection of hiv p24/p26 antigens and antibodies to hiv1/o/2 inhuman serum and plasma using the access immunoassay systems.

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

thermo fisher scientific australia pty ltd - ct2186 - multiple hla/hna/hpa typing antigen/antibody ivds - labscreen multi is a diagnostic tool intended for the detection of antibodies to human leukocyte antigens or detection of antibodies to human neutrophil antigens.

Australia - Inggris - 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 - Inggris - 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 - Inggris - 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 - Inggris - 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 - a chemiluminescent microparticle immunoassay for the qualitative determination of anti-hbc in clinical specimens. a chemiluminescent microparticle immunoassay for the qualitative determination of anti-hbc in clinical specimens

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

abbott australasia pty ltd diagnostic division - 49713 - cytomegalovirus (cmv) immunoglobulin g (igg) antibody ivd, kit, chemiluminescent immunoassay - a chemiluminescent microparticle immunoassay for the qualitative detection and semi-quantitative determination of igg antibodies to cytomegalovirus in clinical specimens. a chemiluminescent microparticle immunoassay for the determination of igg antibodies to cytomegalovirus in clinical specimens.