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

roche diagnostics australia pty limited - 48218 - hiv1/hepatitis c virus/hepatitis b virus nucleic acid ivd, control - cobas hbv/hcv/hiv-1 control kit contains a low positive control, high positive control and negative control and is to be used as a batch control for the cobas hbv, cobas hcv, and cobas hiv-1 tests for use on the cobas 4800 system (nucleic acid technique). cobas hbv/hcv/hiv-1 control kit is used for the quality control of the cobas hbv, cobas hcv, and cobas hiv-1 tests for use on the cobas 4800 system.

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

roche diagnostics australia pty limited - 30768 - hiv1 nucleic acid ivd, kit, nucleic acid technique (nat) - as a quantitative test, this test can be used for confirmation of hiv-1 infection in antibody reactive individuals and to assess patient prognosis or to monitor the effects of antiretroviral therapy. as a qualitative test with dried blood spots, detection of hiv-1 nucleic acids is indicative of active hiv-1 infection in infants born to hiv-infected mothers who have maternal antibodies to hiv-1. cobas hiv-1 is an in vitro nucleic acid amplification test for the quantitation of human immunodeficiency virus type 1 (hiv-1) in edta plasma or from a cobas plasma separation card (psc) dried plasma spot and for the qualitative detection of hiv-1 in dried blood spots of hiv-1-infected individuals including infants born to mothers infected with hiv-1. this test is to be used with the cobas 4800 system. it is intended for use in conjunction with clinical presentation and other laboratory markers of disease progression for the clinical management of hiv-1-infected patients.

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

roche diagnostics australia pty limited - 48218 - hiv1/hepatitis c virus/hepatitis b virus nucleic acid ivd, control - cobas hbv/hcv/hiv-1 control kit contains a low positive control and high positive control and is to be used as a batch control for the cobas hbv, cobas hcv, and cobas hiv-1 tests for use on the cobas 6800/8800 systems (nucleic acid technique). cobas hbv/hcv/hiv-1 control kit is used for the quality control of the cobas hbv, cobas hcv, and cobas hiv-1 tests for use on the cobas 6800/8800 systems.

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

roche diagnostics australia pty limited - 48374 - hepatitis c virus nucleic acid ivd, kit, nucleic acid technique (nat) - cobas? hcv enables the detection and quantitation of hcv rna in edta plasma or serum of infected patients. hcv genotypes 1-6 are detected and quantified but not discriminated. a non-hcv armored rna quantitation standard (rna-qs) is introduced into each specimen during sample preparation, and is used to quantify the viral load and act as an internal control to monitor the entire sample preparation and pcr amplification process. three external controls are also employed. cobas? hcv is an in vitro nucleic acid amplification test for both the detection and quantitation of hepatitis c virus (hcv) rna, in human edta plasma or serum, of hcv-infected individuals.

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

roche diagnostics australia pty limited - 48374 - hepatitis c virus nucleic acid ivd, kit, nucleic acid technique (nat) - cobas? hcv enables the detection and quantitation of hcv rna in edta plasma or serum of infected patients. hcv genotypes 1-6 are detected and quantified but not discriminated. a non-hcv armored rna quantitation standard (rna-qs) is introduced into each specimen during sample preparation, and is used to quantify the viral load and act as an internal control to monitor the entire sample preparation and pcr amplification process. three external controls are also employed. cobas? hcv is an in vitro nucleic acid amplification test for both the detection and quantitation of hepatitis c virus (hcv) rna, in human edta plasma or serum, of hcv-infected individuals.

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

roche diagnostics australia pty limited - 62541 - coagulation analyser ivd, home-use, battery-powered - instruments designed to be used at the point of care setting by both healthcare professionals and patients for self monitoring.

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

roche diagnostics australia pty limited - ct872 - coagulation calibrator/control ivds - ivds that are intended to be used in testing to establish known points of reference and/or verify the performance of coagulation assays

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

roche diagnostics australia pty limited - ct705 - hepatitis c virus ivds - 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)

roche diagnostics australia pty limited - 61304 - pcr/nat negative control ivd - the cobas? nhp negative control kit contains normal human plasma and is to be used as a negative batch control for the cobas? mpx test. the cobas? nhp negative control kit is intended for use on the cobas? 6800/8800 systems as a negative batch control.

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

roche diagnostics australia pty limited - 48216 - hiv1/hepatitis c virus/hepatitis b virus nucleic acid ivd, kit, nucleic acid technique (nat) - a qualitative multiplex nucleic acid test for use on the cobas 6800/8800 systems to screen human plasma and serum samples for the simultaneous direct detection of hiv, hcv and hbv. the test does not discriminate between hiv-1 group m, hiv-1 group o, and hiv-2. the cobas mpx test is a multiplex hiv, hcv and hbv nucleic acid test for use in human plasma and serum, intended to screen individual donor samples for whole blood and blood components in living donors, and organ and tissue donors in both living and cadaveric donors. the test can also be used for donations of source plasma in pools of no more than 96 individual samples when the source plasma is intended for further manufacture into plasma derived products that undergo pathogen inactivation and/or removal procedures.