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

h3 diagnostics pty ltd - ct847 - clinical chemistry vitamin and mineral ivds - the products under this registration are reagent kits intended to be used on immunoassay analyzers to detect the presence and determine the concentration of various vitamin and mineral in a given sample for diagnostics purpose. the products are to be used in a laboratory setting and operated by professionally trained staff. the results generated by these reagent kits are to be interpret by professionally trained physicians or general practitioners.

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

hyp investment pty ltd - ct845 - clinical chemistry tumour marker ivds - the products under this registration are reagent kits intended to be used on immunoassay analyzers to detect the presence and determine the concentration of various tumor markers in a given sample for diagnostics purpose. the products are to be used in a laboratory setting and operated by professionally trained staff. the results generated by these reagent kits are to be interpret by professionally trained physicians or general practitioners.

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

hyp investment pty ltd - ct869 - clinical chemistry autoimmune ivds - the products under this registration are reagent kits intended to be used on immunoassay analyzers to detect the presence and determine the concentration of various autoimmune antigens in a given sample for diagnostics purpose. the products are to be used in a laboratory setting and operated by professionally trained staff. the results generated by these reagent kits are to be interpret by professionally trained physicians or general practitioners.

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

3p pty ltd - ct850 - clinical chemistry hormone ivds - an ivd intended to be used for the rapid qualitative determination of human chorionic gonadotropin (hcg) in human urine samples, as an aid in the early detection of pregnancy; and an ivd intended to be used for the rapid qualitative determination of luteinizing hormone (lh) inn human urine samples as an aid in the prediction of ovulation.

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

frostbland pty ltd - ct974 - clinical chemistry-specific protein ivds - the ferritin rapid test cassette is a rapid test for the qualitative detection of ferritin in human fingerstick blood for iron deficiency anemia. for self-testing in vitro diagnostic use only.

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

abbott rapid diagnostics pty ltd - ct287 - clinical chemistry ivds - rapid immunoassay for the qualitative detection of human chorionic gonadotropin (hcg) for early detection of pregnancy.

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

faju pty ltd - ct850 - clinical chemistry hormone ivds - b?b? bloom offers a range of different self-performing ivd urine tests for the detection of pregnancy and ovulation. two of the tests assess the qualitative determination of human chorionic gonadotropin hormone (hcg). the sensitivity offered is 10miu/ml and 25miu/ml. the gmdn number is 33819. also, we offer a semi-quantitative ovulation test, which detects the luteinizing hormone (lh). the test assists to predict the surge of the hormone, which leads to ovulation. the gmdn number is 54255

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

r & r services australia pty ltd - ct974 - clinical chemistry-specific protein ivds - the nk vue elisa is an ifn-? quantitation assay for plasma samples collected and prepared with the nk vue tube (available separately). nk vue is intended for in vitro diagnostic use, for the monitoring of the immune status of individuals. measurement of nk cell activity could be a useful tool for assessing changes in immunosurveillance, which, in turn, could be indicative of a condition or disease where nk cell activity has been shown to be affected

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

thermo fisher scientific australia pty ltd - ct184 - clinical chemistry toxicology/drug detection ivds - the microscreen 2 drug screen cup is a rapid lateral flow immunoassay for the qualitative detection of multiple drugs and/or drug metabolites in human urine.

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

immuno pty ltd - ct1236 - clinical chemistry biological screening ivds - ivds that are intended to be used for the qualitative and/or quantitative screening of semen specimens. for laboratory use only.