Australien - engelsk - Department of Health (Therapeutic Goods Administration)

abbott rapid diagnostics pty ltd - 48447 - hiv1/hiv2 antigen/antibody ivd, kit, immunochromatographic test (ict), rapid - determine hiv early detect is an immunochromatographic test for the qualitative detection of hiv-1 p24 antigen and antibodies to hiv-1 and hiv-2. determine hiv early detect is an in vitro, visually read, qualitative immunoassay for the detection of antibodies (ab) to hiv-1 and hiv-2 and the detection of non-immunocomplexed (free) hiv-1 p24 antigen (ag) in human capillary and venous whole blood, plasma or serum. therefore, any reactivity on 1) the ab bar alone 2) the ag bar alone or 3) both the ab and ag bars simultaneously, is considered a reactive result suggestive of infection with hiv. the test is for professional use only and intended to be used as an aid in the diagnosis of hiv-1/hiv-2 infection in adults and children over the age of 18 months.

Australien - engelsk - Department of Health (Therapeutic Goods Administration)

paragon care group australia pty ltd trading as immulab - ct2186 - multiple hla/hna/hpa typing antigen/antibody ivds - for use in solid phase assays to detect igg hla and platelet-specific antibodies to platelets.

Australien - engelsk - Department of Health (Therapeutic Goods Administration)

bio-rad laboratories pty ltd - 48449 - hiv1/hiv2 antigen/antibody ivd, control - the access hiv combo qc is intended for monitoring system performance of the access hiv combo assay. the access hiv combo qc is intended for monitoring system performance of the access hiv combo assay.

Australien - engelsk - Department of Health (Therapeutic Goods Administration)

bio-rad laboratories pty ltd - 48448 - hiv1/hiv2 antigen/antibody ivd, calibrator - the access hiv combo calibrators are intended to calibrate the access hiv combo assay for the qualitative detection of hiv-1 antigen and antibodies to hiv-1/hiv-1-o/hiv-2 in human serum and plasma using the access immunoassay systems. the access hiv combo calibrators are intended to calibrate the access hiv combo assay for the qualitative detection of hiv-1 antigen and antibodies to hiv-1/hiv-1-o/hiv-2 in human serum and plasma using the access immunoassay systems.

Australien - engelsk - Department of Health (Therapeutic Goods Administration)

biomerieux australia pty ltd - 48445 - hiv1/hiv2 antigen/antibody ivd, kit, enzyme immunoassay (eia) - an automated hiv infection screening test for use on the vidas family instruments, for the combined detection of anti-hiv-1 (groups m and o) and anti-hiv-2 total immunoglobulins and hiv-1 p24 antigen in human serum or plasma (lithium heparin or edta) using the elfa technique (enzyme linked fluorescent assay). an automated hiv infection screening test for use on the vidas family instruments, for the combined detection of anti-hiv-1 (groups m and o) and anti-hiv-2 total immunoglobulins and hiv-1 p24 antigen in human serum or plasma (lithium heparin or edta) using the elfa technique (enzyme linked fluorescent assay).

Australien - engelsk - 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

Australien - engelsk - Department of Health (Therapeutic Goods Administration)

bio-rad laboratories pty ltd - 48445 - hiv1/hiv2 antigen/antibody ivd, kit, enzyme immunoassay (eia) - a qualitative enzyme immunoassay kit for the detection of hiv p24 antigen and antibodies to hiv-1 (groups m and o) and hiv-2 in human serum or plasma. the genscreen? ultra hiv ag-ab is a qualitative enzyme immunoassay kit for the detection of hiv p24 antigen and antibodies to hiv-1 (groups m and o) and hiv-2 in human serum or plasma. this kit can be used for both hiv ag and hiv ab screening

Australien - engelsk - 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-1 p24 antigen, antibodies to hiv-1 (group m and group o), and antibodies to hiv-2 in human serum and plasma using chemiluminescent microparticle immunoassay (cmia) technology. the alinity s hiv ag/ab combo assay is a chemiluminescent microparticle immunoassay (cmia) used for the simultaneous qualitative detection of human immunodeficiency virus (hiv) p24 antigen and antibodies to hiv type 1 (hiv-1 group m and group o) and/or type 2 (hiv-2) in human serum and plasma, including specimens collected up to 24 hours postmortem (non-heart-beating), on the alinity s system.

Australien - engelsk - Department of Health (Therapeutic Goods Administration)

roche diagnostics australia pty limited - 48449 - hiv1/hiv2 antigen/antibody ivd, control - precicontrol hiv; hiv-2+grpo is a lyophilized control serum based on human serum. the controls are used for monitoring the accuracy of the elecsys hiv combi pt and elecsys hiv duo assays. precicontrol hiv; hiv-2grpo is used for quality control of the elecsys hiv combi pt and elecsys hiv duo immunoassays on the elecsys and cobas e immunoassay analysers

Australien - engelsk - Department of Health (Therapeutic Goods Administration)

roche diagnostics australia pty limited - 48449 - hiv1/hiv2 antigen/antibody ivd, control - precicontrol hiv gen ii is a lyophilized control serum based on human serum. the control levels 1, 2 and 3 are used for monitoring the accuracy of the elecsys hiv combi pt and elecsys hiv duo assays. the control levels 1 and 3 are used for monitoring the accuracy of the elecsys hiv ag assay. precicontrol hiv gen ii is used for quality control of the elecsys hiv combi pt, elecsys hiv duo and elecsys hiv ag immunoassays on the elecsys and cobas e immunoassay analysers