Австралия - английски - Department of Health (Therapeutic Goods Administration)

thermo fisher scientific australia pty ltd - ct889 - multiple clinical chemistry constituent ivds - ivds intended to be used for the qualitative and/or quantitative determination of multiple analytes (chemical, biological, and/or immunological) from more than one clinical chemistry specialty, in a clinical specimen

Австралия - английски - Department of Health (Therapeutic Goods Administration)

thermo fisher scientific australia pty ltd - ct1236 - clinical chemistry biological screening ivds - ivds intended to be used for the qualitative and/or quantitative screening of urine, faeces and other biological specimens for chemical, cellular or other components using a dipstick or other broadly indicative method. for laboratory use only

Австралия - английски - Department of Health (Therapeutic Goods Administration)

thermo fisher scientific australia pty ltd - ct845 - clinical chemistry tumour marker ivds - ivds intended for use in the clinical laboratory as quantitative controls for monitoring test procedures used to assay human serum for tumour markers

Австралия - английски - 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.

Австралия - английски - 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

Австралия - английски - 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

Австралия - английски - 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

Австралия - английски - 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

Австралия - английски - 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.

Австралия - английски - Department of Health (Therapeutic Goods Administration)

abbott australasia pty ltd diagnostic division - ct860 - clinical chemistry therapeutic drug monitoring ivds - for the determination of therapeutic drug levels in human clinical specimens.