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

thermo fisher scientific australia pty ltd - ct847 - clinical chemistry vitamin and mineral ivds - the cascadion? sm 25-hydroxy vitamin d assay is for the determination of total 25-hydroxy vitamin d (25-oh vit d) in human serum and plasma through the quantitative measurement and combination of 25-hydroxy vitamin d3 and 25-hydroxy vitamin d2 on the cascadion? sm clinical analyzer. this liquid- chromatography ? tandem mass spectrometry (lc-ms/ms) assay is to be used as an aid in the assessment of vitamin d sufficiency.

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

thermo fisher scientific australia pty ltd - ct866 - immunosuppressant therapeutic drug monitoring ivds - the cascadion? sm immunosuppressants panel is for the quantitative determination of cyclosporin a, sirolimus, tacrolimus, and everolimus in human whole blood by a single injection on the cascadion? sm clinical analyzer. this liquid-chromatography ? tandem mass spectrometry (lc-ms/ms) assay is to be used as an aid in the management of transplant patients receiving therapies with these drugs. this in vitro diagnostic device is intended for clinical laboratory use only.

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

thermo fisher scientific australia pty ltd - ct899 - tissue typing-related ivds - devices designed for rapid isolation of peripheral blood t lymphocytes cd8+ (hla class 1 positive cells) and peripheral blood b lymphocytes cd4+ (hla class ii positive cells) suitable as target cells in microcytotoxic hla-typing assay.

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

thermo fisher scientific australia pty ltd - 35704 - freezer, blood product - the plasma freezers (pfs) are intended for the storage of blood and blood products in a frozen state. all materials stored in these products must be in sealed blood bags. product must not be stored in open containers.

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

thermo fisher scientific australia pty ltd - 35486 - refrigerator, blood - the blood bank refrigerators (bbrs) are intended for the storage of blood and blood products. all materials stored in the bbrs must be in sealed blood bags. blood and blood products must not be stored in open containers.

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

thermo fisher scientific australia pty ltd - ct936 - specimen receptacle ivds - a container intended for the collection, containment, preservation and/or transport of clinical specimens.

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

thermo fisher scientific australia pty ltd - 56648 - assisted reproduction procedure dish - a sterile container intended for preparing and culturing gametes or embryos for use in assisted reproduction techniques (art). such techniques include in vitro fertilization (ivf), fertilization via intracytoplasmic sperm injection (icsi), or other in ivf procedures. this is a single-use device.

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

thermo fisher scientific australia pty ltd - ct827 - clinical chemistry enzyme ivds - intended to be used for the qualitative and/or quantitative determination of clinical chemistry enzymes in a clinical specimen

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

thermo fisher scientific australia pty ltd - ct833 - clinical chemistry substrate ivds - intended to be used for the qualitative and/or quantitative determination of clinical chemistry substrates in a clinical specimen

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

thermo fisher scientific australia pty ltd - ct860 - clinical chemistry therapeutic drug monitoring ivds - intended to be used in monitoring of therapeutic drug levels in a clinical specimen