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

grifols australia pty ltd - ct910 - interpretive software ivds - a1at genotyping test analysis software used in a1at genotyping kit which is a qualitative, polymerase chain reaction (pcr) and hybridization-based in vitro diagnostic test to be used with the luminex 200tm instrument (with xponent? software) for the simultaneous detection and identification of 14 allelic variants and their associated alleles found in the alpha-1 antitrypsin (a1at) codifying gene serpina1. the test is intended for use with genomic dna extracted from human whole blood samples collected as dry blood spots (dbs) or in k2-edta. the a1at allelic variant genotypes and associated allele results, when used in conjunction with clinical findings and other laboratory tests, are intended as an aid in the diagnosis of individuals with a1at deficiency (a1atd).

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

grifols australia pty ltd - ct903 - inborn/inherited genetic disorder ivds - the progenika a1at genotyping kit (reagents and software) is a qualitative, polymerase chain reaction (pcr) and hybridization-based in vitro diagnostic test for the simultaneous detection and identification of 14 allelic variants and their associated alleles found in the alpha-1 antitrypsin (a1at) codifying gene serpina1. the test is intended for use with genomic dna extracted from human whole blood samples collected as dry blood spots (dbs) or in edta and from human saliva samples collected as buccal swabs the a1at allelic variant genotypes and associated allele results, when used in conjunction with clinical findings and other laboratory tests, are intended as an aid in the diagnosis of individuals with a1at deficiency (a1atd).

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

dbs australia pty ltd -

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

dbs australia pty ltd -

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

boston scientific pty ltd - 61552 - deep brain electrical stimulation system lead - the device has directional electrodes that are separated circumferentially. this will allow for both axial and rotational stimulation selectivity. this procedure kit contains surgical accessories. the device is indicated for use in the following: ? unilateral or bilateral stimulation of the subthalamic nucleus (stn) or internal globus pallidus (gpi) for levodopa-responsive parkinson?s disease which is not adequately controlled with medication. ? unilateral or bilateral stimulation of the subthalamic nucleus (stn) or internal globus pallidus (gpi) for intractable primary and secondary dystonia, for persons 7 years of age and older. ? thalamic stimulation for the suppression of tremor not adequately controlled by medications in patients diagnosed with essential tremor or parkinson?s disease.

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

boston scientific pty ltd - 61393 - multi-purpose electrical stimulation system programmer - the remote control is a hand-held device that communicates with the stimulator through a radio frequency (rf) telemetry link. the remote control provides patients with the ability to access basic stimulator functions, such as changing stimulation level and turning stimulation on and off.

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

boston scientific pty ltd - 61393 - multi-purpose electrical stimulation system programmer - the remote control is a hand-held device that communicates with the stimulator through a radio frequency (rf) telemetry link. the kit includes accessories such as a silicone case, holster and usb power supply. the remote control provides patients with the ability to access basic stimulator functions, such as changing stimulation level and turning stimulation on and off.

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

boston scientific pty ltd - 61393 - multi-purpose electrical stimulation system programmer - the remote control is a hand-held device that communicates with the stimulator through a bluetooth low energy telemetry link. the remote control provides patients with the ability to access basic stimulator functions, such as changing stimulation level and turning stimulation on and off

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

boston scientific pty ltd - 61393 - multi-purpose electrical stimulation system programmer - the remote control is a hand-held device that communicates with the stimulator through a bluetooth low energy telemetry link. the remote control provides patients with the ability to access basic stimulator functions, such as changing stimulation level and turning stimulation on and off

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

medtronic australasia pty ltd -