Аустралија - Енглески - Department of Health (Therapeutic Goods Administration)

agilent technologies australia pty ltd - ct929 - acquired genetic alteration ivds - the intended purpose is to determine acquired genetic alterations

Аустралија - Енглески - Department of Health (Therapeutic Goods Administration)

abacus dx pty ltd - ct929 - acquired genetic alteration ivds - an in vitro medical device intended to be used in genetic testing to provide information about acquired genetic alternations, which may include chromosomal alterations, mutations and/or alterations in gene expression, and which may be used to characterise haematological or solid tumour malignancies and/or provide prognostic information.

Аустралија - Енглески - Department of Health (Therapeutic Goods Administration)

abacus dx pty ltd - ct929 - acquired genetic alteration ivds - to be used in genetic testing to provide information about acquired genetic alterations

Аустралија - Енглески - 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.

Аустралија - Енглески - Department of Health (Therapeutic Goods Administration)

abacus dx pty ltd - ct929 - acquired genetic alteration ivds - to be used in genetic testing to provide information about acquired genetic alterations

Аустралија - Енглески - Department of Health (Therapeutic Goods Administration)

sysmex australia pty ltd - ct906 - human genetics-related ivds - ivds that are intended to be used alone or in combination with other ivds to perform various human genetics-related tests and procedures (e.g. chromosomal rearrangements, chromosome and dna sequences).

Аустралија - Енглески - Department of Health (Therapeutic Goods Administration)

diagnostic technology pty ltd - ct902 - human genetics ivds - ivds that are intended to be used in genetic testing to provide information about inborn or inherited genetic disorders, mitochondrial disorders, constitutional chromosome disorders and/or acquired genetic alterations.

Аустралија - Енглески - Department of Health (Therapeutic Goods Administration)

roche diagnostics australia pty limited - ct903 - inborn/inherited genetic disorder ivds - in vitro diagnostic reagent kits for the detection of various inborn and/or genetic disorder targets using molecular techniques

Аустралија - Енглески - Department of Health (Therapeutic Goods Administration)

revvity pty ltd - ct903 - inborn/inherited genetic disorder ivds - inborn/inherited genetic disorder ivds

Аустралија - Енглески - Department of Health (Therapeutic Goods Administration)

sysmex australia pty ltd - ct929 - acquired genetic alteration ivds - ivds that are intended to be used in genetic testing to provide information about acquired genetic alterations, which may include chromosomal alterations, mutations and/or alterations in gene expression, and which may be used to characterise haematological or solid tumour malignancies and/or provide prognostic information. these products are intended for use as an adjunct to classic cytogenetics and not as independent tests or assays.