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

qiagen pty ltd - ct929 - acquired genetic alteration ivds - the ipsogen jak2 rgq pcr kit is a quantitative in vitro pcr assay intended for the detection and quantitation of the jak2 v617f/g1849t mutation in genomic dna extracted from human peripheral whole blood anticoagulated with 2k-edta. results obtained with the ipsogen jak2 rgq pcr kit are intended for use as an adjunct to evaluation of suspected philadelphia (ph) chromosome negative myeloproliferative neoplasm (mpn) and molecular disease monitoring in mpn patients. any diagnostic results generated must be interpreted in conjunction with other clinical-pathological findings. the ipsogen jak2 rgq pcr kit is intended to be used only with the qiagen rotor-gene q mdx 5plex hrm instrument and other validated workflow components as outlined in the instructions for use. the ipsogen jak2 rgq pcr kit is not an automated device, however, the analysis is assisted by a dedicated software. the ipsogen jak2 rgq pcr kit is intended for in vitro diagnostic use.

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

qiagen pty ltd - ct704 - hepatitis b virus ivds - the artus hbv kit is an in vitro nucleic acid amplification test for the quantitation of hepatitis b virus (hbv) dna in human edta plasma. this diagnostic test kit utilizes the polymerase chain reaction (pcr) and is configured for use with the qiasymphony sp/as and rotor-gene q instruments. the artus hbv qs-rgq kit is intended for use in conjunction with clinical presentation and other laboratory markers for disease prognosis and for use as an aid in assessing viral response to antiviral treatment as measured by changes in human edta plasma hbv dna levels. the artus hbv qs-rgq kit is not intended to be used as a screening test for hbv or as a diagnostic test to confirm the presence of hbv infection.

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

qiagen pty ltd - ct946 - general laboratory reagent and consumables ivds - ivds that are general laboratory reagents, products or consumables, that are intended to be used as an aid in the testing of specimens within a clinical laboratory, including the extraction of nucleic acid from a variety of biological specimens.

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

qiagen pty ltd - ct705 - hepatitis c virus ivds - the artus hcv kit is an in vitro nucleic acid amplification test for the quantitation of hepatitis c virus (hcv) rna in human edta plasma. this diagnostic test kit utilizes the reverse transcription polymerase chain reaction (rt-pcr) and is configured for use with the qiasymphony sp/as and rotor-gene q instruments. the artus hcv qs-rgq kit is intended for use in conjunction with clinical presentation and other laboratory markers for disease prognosis and for use as an aid in assessing viral response to antiviral treatment as measured by changes in human edta plasma hcv rna levels. the artus hcv kit is not intended to be used as a screening test for hcv or as a diagnostic test to confirm the presence of hcv infection.

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

qiagen pty ltd - ct284 - human immunodeficiency virus (hiv) ivds - the artus hi virus-1 qs-rgq kit is an in vitro nucleic acid amplification test for the quantitation of human immunodeficiency virus type 1 (hiv-1) rna in human edta plasma. this diagnostic test kit utilizes the reverse transcription polymerase chain reaction (rt-pcr) and is configured for use with the qiasymphony sp/as and rotor-gene q instruments. plasma samples containing group m subtypes a?h have been validated for use in the assay. the artus hi virus-1 qs-rgq kit is intended for use in conjunction with clinical presentation and other laboratory markers for disease prognosis and for use as an aid in assessing viral response to antiretroviral treatment as measured by changes in human edta plasma hiv-1 rna levels. the artus hi virus-1 qsrgq kit is not intended to be used as a screening test for hiv or as a diagnostic test to confirm the presence of hiv infection.

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

qiagen pty ltd - ct749 - herpes simplex virus (hsv) (human herpesvirus 1 & 2) ivds - ivd's for the detection of human herpes simplex virus 1 and 2 dna from human biological samples

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

qiagen pty ltd - ct748 - cytomegalovirus (human herpesvirus 5) ivds - ivd's for the quantitation of cytomegalovirus (cmv) dna in human biological samples

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

qiagen pty ltd - ct758 - bk virus ivds - ivd's for the quantitation of bk virus (bkv) dna in human biological samples

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

qiagen pty ltd - ct921 - enterococcus ivds - ivd's intended for the qualitative detection of nucleic acids encoding vana and vanb vancomycin resistance genes from patients at risk for vancomycin resistant enterococcus (vre) colonisation.

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

qiagen pty ltd - ct791 - mycobacteria ivds - ivd test kits and controls for the detection of mycobacterium tuberculosis infection (including disease)