Ausztrália - angol - Department of Health (Therapeutic Goods Administration)

roche diagnostics australia pty limited - ct943 - instrument/analyser ivds - instruments intended for the in vitro diagnostic analysis of biological samples, designed to be used at the point of care setting by healthcare professionals, for use by patients for self monitoring, and/or for use in clinical laboratory settings.

Ausztrália - angol - Department of Health (Therapeutic Goods Administration)

roche diagnostics australia pty limited - ct943 - instrument/analyser ivds - instruments used at the point of care setting by health care professionals (gp, pharmacies, clinics, hospita; wards)

Ausztrália - angol - Department of Health (Therapeutic Goods Administration)

roche diagnostics australia pty limited - ct943 - instrument/analyser ivds - automated clinical analytical systems designed to analyse biological samples for in vitro diagnostic purposes

Ausztrália - angol - 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.

Ausztrália - angol - Department of Health (Therapeutic Goods Administration)

roche diagnostics australia pty limited - 42000 - hepatitis b virus surface antigen ivd, control - a ready to use control serum based on human serum both in the negative and positive concentration range. for quality control of the elecsys hbsag ii and elecsys hbsag ii auto confirm immunoassays on the elecsys and cobas e immunoassay analysers.

Ausztrália - angol - Department of Health (Therapeutic Goods Administration)

roche diagnostics australia pty limited - ct846 - prostate specific marker ivds - the elecsys total and free psa immunoassays, are quantitative in vitro diagnostic tests for total (free + complexed) as well as free prostate-specific antigen in human serum and plasma, are indicated for the measurement of psa in conjunction with digital rectal examination (dre) as an aid in the detection of prostate cancer in men aged 50 years or older. prostate biopsy is required for diagnosis of prostate cancer. the tests are further indicated for serial measurement of psa to aid in the management of cancer patients. the electrochemiluminescence immunoassay ?eclia? is intended for use on elecsys and cobas e immunoassay analyzers. gmdns code and description: prostate specific marker ivds[ct846]

Ausztrália - angol - Department of Health (Therapeutic Goods Administration)

roche diagnostics australia pty limited - ct771 - rubella virus ivds - immunoassays for the qualitative determination of igm and igg antibodies to rubella virus (two separate assays). intended for use on elecsys and cobas e immunoassya analysers

Ausztrália - angol - Department of Health (Therapeutic Goods Administration)

roche diagnostics australia pty limited - ct820 - toxoplasma ivds - immunoassays for the in vitro qualitative determination of igg antibodies, the qualitative determination of the avidity of igg antibodies and the qualitative determination of igm antibodies to toxoplasma gondii, including their respective control materials in human serum and plasma

Ausztrália - angol - Department of Health (Therapeutic Goods Administration)

roche diagnostics australia pty limited - ct1242 - troponin ivds - ivds that are intended to be used for the qualitative and/or quantitative determination of troponin and its various forms in a clinical specimen.

Ausztrália - angol - Department of Health (Therapeutic Goods Administration)

roche diagnostics australia pty limited - 30768 - hiv1 nucleic acid ivd, kit, nucleic acid technique (nat) - 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. 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 of hiv-1-infected individuals. this test is to be used with the cobas 6800 system and cobas 8800 system. it is intended for use in conjunction with clinical presentation and other laboratory markers for the clinical management of hiv-1-infected patients.