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

vitryl aus pty ltd - 11961 - shield, face - this is a device that made of a clear, transparent guard that is intended to be worn over the face to protect the healthcare worker from blood and other body fluid splashes while performing a clinical procedures.

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

h3 diagnostics pty ltd - ct943 - instrument/analyser ivds - the union automated immunology analyzer is an automated in vitro diagnostic instrument for analyzing a variety of immunoassays. the immunoassay kits are provided separately. the union automated immunology analyzer is to be used in a laboratory for analyzing the presence/absence and quantity of a particular hormone/protein/enzyme/mineral, the result generated will be used to diagnose patient's illness.

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

hyp investment pty ltd - ct943 - instrument/analyser ivds - the products under this registration are analyzers intended to be used in laboratory setting. these analyzers cover both manual operation analyzers and fully automatic analyzers, and these products are to be operated by professionally trained staff to generate results for diagnostic purposes. these analyzers cover a wide range of applications and are used in various disciplines in the ivd industry including, but are not exclusive to haematology, immunology, clinical chemistry and more.

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

hyp investment pty ltd - ct889 - multiple clinical chemistry constituent ivds - the products under this registration are multi control kits to be used on immunoassay analyzers to ensure the instrument and respective reagent kit are functioning as intended and performing optimally. the products are to be used in a laboratory setting and operated by professionally trained staff. the results generated by the control kits are not for diagnostic purpose and it is only to be used by laboratory staff to determine the performance of the instrument and the targeting reagent kit(s). the products also consist of reagent kits with multiple testing parameters, these kits are to be used on immunoassay analyzers to detect the presence and determine the concentration of multiple substance including, but are not exclusive to, specific proteins, hormones and antigens. these 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 - English - Department of Health (Therapeutic Goods Administration)

h3 diagnostics pty ltd - ct833 - clinical chemistry substrate 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 chemistry substrates 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 - English - Department of Health (Therapeutic Goods Administration)

h3 diagnostics pty ltd - ct974 - clinical chemistry-specific protein 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 specific proteins 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 - English - Department of Health (Therapeutic Goods Administration)

h3 diagnostics pty ltd - ct748 - cytomegalovirus (human herpesvirus 5) 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 cytomegalovirus antibodies 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 - English - Department of Health (Therapeutic Goods Administration)

h3 diagnostics pty ltd - ct771 - rubella virus 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 rubella virus antibodies in a given sample for diagnostic purpose. the products are to be used in a laboratory setting and operated by professionally trained laboratory staff. the results generated by these reagent kits are to be interpret by professionally trained physicians or general practitioners

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

h3 diagnostics pty ltd - ct846 - prostate specific 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 prostate specific 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 - English - Department of Health (Therapeutic Goods Administration)

hyp investment pty ltd - ct355 - viral infectious disease 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 viral 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.