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

thermo fisher scientific australia pty ltd - ct929 - acquired genetic alteration ivds - acquired genetic alteration control intended for use with next generation sequencing (ngs) assays that are designed to identify somatic mutations in dna from human samples. the control is intended to provide a means for assessing day-to-day test variation and may help in identifying increases in random or systematic error, such as reagent lot changes, operator-based deviations, and instrument malfunction.

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

thermo fisher scientific australia pty ltd - ct355 - viral infectious disease ivds - non assay-specific viral infectious disease quality control material intended to detect viral dna/rna or antibodies in human serum samples

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

thermo fisher scientific australia pty ltd - ct353 - bacterial infectious disease ivds - non assay-specific bacterial infectious disease quality control material intended for use in assessing the performance of nucleic acid test procedures for the presence of bacterial dna

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

medical manufacturers pty ltd - 42572 - ophthalmic cannula, irrigation/aspiration, fibreoptic, single-use - for: fluid infusion and aspiration during surgery; catheterisation and viscodilation of schlemms canal; placement of a tensing suture within the canal to reduce the iop of patients with glaucoma

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

medical manufacturers pty ltd - 36185 - laser delivery unit, fibreoptic - light source intended to provide illumination during ophthalmic surgery.

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

thermo fisher scientific australia pty ltd - ct356 - parasitic infectious diseases ivds - non-assay specific parasitic infectious disease quality control material intended to detect parasitic dna, antibodies, or antigens in human serum samples

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

stryker australia pty ltd - 34099 - valve, backflow, in-line, single use - intended to provide a fluid tight seal and prevent back flow during endovascular procedures.

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

thermo fisher scientific australia pty ltd - ct866 - immunosuppressant therapeutic drug monitoring ivds - ivds that are intended to be used in therapeutic monitoring of drugs [mycophenolic acid, tacrolimus, cyclosporine, everolimus] targeting the immune system in a clinical specimen

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

abbott australasia pty ltd diagnostic division - ct184 - clinical chemistry toxicology/drug detection ivds - for the detection of drugs and/or toxic substances in human clinical specimens.

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

stryker australia pty ltd - 32584 - catheter, intravascular, occluding - transform occlusion balloon catheters are advanced into the vasculature and a mixture of saline and contrast is injected into the catheter lumen to inflate the balloon to its nominal volume while fluoroscopy is used to ensure the balloon is properly positioned at the treatment site. the balloon is deflated by aspirating fluid from the catheter while visually confirming deflation with fluoroscopy. the balloon can be re-inflated and deflated multiple times during a procedure. the stryker neurovascular transform occlusion balloon catheter is indicated for use in the neurovasculature to temporarily stop or control blood flow, for balloon-assisted coil embolization of intracranial aneurysms, and as an adjunct to the medical management of vasospasms or the treatment of refractory symptomatic cerebral vasospasms. the stryker neurovascular transform occlusion balloon catheter is indicated for use in the peripheral vasculature to temporarily stop or control blood flow, and for balloon-assisted coil embolization of aneurysms.