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

mp biomedicals australasia pty ltd - ct353 - bacterial infectious disease ivds - ivds for the qualitative and/or quantitative detection of bacterial antigens and/or antibodies in human specimens.

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

mp biomedicals australasia pty ltd - ct850 - clinical chemistry hormone ivds - qualitative and/or quantitative detection of hormones in clinical samples.

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

mp biomedicals australasia pty ltd - ct707 - hepatitis e virus ivds - ivds for the quantitative and/or qualitative detection of hepatitis e virus antigens or antibodies in human specimens.

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

mp biomedicals australasia pty ltd - 48367 - hepatitis c virus total antibody ivd, kit, immunoblot - the mp diagnostics hcv blot 3.0 western blot kit includes structural and nonstructural antigens from hcv and is intended as supplemental confirmatory assay for presence of antibodies to hcv mp diagnostics hcv blot 3.0 is a qualitative enzyme immunoassay for the in vitro detection of antibodies to hcv in human serum or plasma. it is intended for use as a more specific supplemental test on specimens found repeatedly reactive using specific procedures such as elisa

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

mp biomedicals australasia pty ltd - 48453 - hiv1/hiv2 antibody ivd, kit, immunoblot - the mp diagnostics hiv blot 2.2 kit is a western blot immunoassay kit intended for use as a more specific supplemental test on human serum or plasma specimens found repeatedly reactive using elisa mp diagnostics hiv blot 2.2 is a qualitative enzyme immunoassay for the in vitro detection of antibodies to human immunodeficiency virus type 1 (hiv-1) and type 2 (hiv-2) in human serum or plasma. it is intended for use as a more specific supplemental test on human serum or plasma specimens found repeatedly reactive using screening procedures such as the enzyme-linked immunosorbent assay (elisa).

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

mp biomedicals australasia pty ltd - 48525 - human t-cell lymphotrophic virus 1 & 2 (htlv1 & htlv2) antibody ivd, kit, immunoblot - the mp diagnostics htlv blot 2.4 is a western blot kit intended as a supplemental antibody assay for characterizing samples found repeatedly reactive by initial htlv-i/ii antibody screening methods. mp diagnostics htlv blot 2.4 is a qualitative enzyme immunoassay for the in vitro detection of antibodies to htlv-i and htlv-ii in human serum or plasma. it is intended for use as a more specific supplemental test on human serum or plasma specimens found repeatedly reactive using screening procedures like the enzyme-linked immunosorbent assays (elisa).

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

mp biomedicals australasia pty ltd - ct725 - dengue virus ivds - to detect antibodies and antigens in human plasma or serum or finger pricked whole blood or whole blood with anti-coagulants. it is intended for professional use as a clinical diagnostic test for diagnosing dengue infected patients.

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

mp biomedicals australasia pty ltd - ct772 - severe acute respiratory syndrome-associated coronavirus ivds - intended to detect the novel coronavirus sars-cov-2 that causes covid-19 from symptomatic individuals at the point of care by trained health professionals (nasal, nasopharyngeal or oropharyngeal swab samples) and for self-testing by lay persons (nasal samples).

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

mp biomedicals australasia pty ltd - ct943 - instrument/analyser ivds - instrumentation intended fore the automated processing of immunoblot assays.

United States - English - NLM (National Library of Medicine)

biomedical research foundation of northwest louisiana - fludeoxyglucose f-18 (unii: 0z5b2cjx4d) (fludeoxyglucose f-18 - unii:0z5b2cjx4d) - fludeoxyglucose f-18 300 mci in 1 ml - fludeoxyglucose f 18 injection usp is indicated for positron emission tomography (pet) imaging in the following settings: for assessment of abnormal glucose metabolism to assist in the evaluation of malignancy in patients with known or suspected abnormalities found by other testing modalities, or in patients with an existing diagnosis of cancer. for the identification of left ventricular myocardium with residual glucose metabolism and reversible loss of systolic function in patients with coronary artery disease and left ventricular dysfunction, when used together with myocardial perfusion imaging. for the identification of regions of abnormal glucose metabolism associated with foci of epileptic seizures. none risk summary data from published case series and case reports describe fludeoxyglucose f 18 injection crossing the placenta with uptake by the fetus (see data). all radiopharmaceuticals have the potential to cause fetal harm depending on the fetal stage of development and the magnitude of the radiation d