Australien - Englisch - Department of Health (Therapeutic Goods Administration)

cepheid holdings pty ltd - ct943 - instrument/analyser ivds - the genexpert system combines on-board sample preparation with real-time pcr (polymerase chain reaction) amplification and detection functions for fully integrated and automated nucleic acid analysis.

Australien - Englisch - Department of Health (Therapeutic Goods Administration)

cepheid holdings pty ltd - ct774 - multiple-bacteria ivds - the ct/ng assay is a qualitative in vitro real-time pcr test for the automated and rapid detection and differentiation of genomic dna from chlamydia trachomatis (ct) and neisseria gonorrhoeae (ng)to aid in the diagnosis of chlamydial and/or gonorrheal urogenital disease.

Australien - Englisch - Department of Health (Therapeutic Goods Administration)

cepheid holdings pty ltd - ct936 - specimen receptacle ivds - specimen collection kit to preserve and transport dna or rna of infectious agent prior to analysis on the genexpert system

Australien - Englisch - Department of Health (Therapeutic Goods Administration)

cepheid holdings pty ltd - ct876 - thrombophilia and coagulation inhibitor ivds - the xpert factor ii & factor v assay is a qualitative ivd genotyping test to detect fii and fv alleles from sodium citrate or edta anticoagulated whole blood. this test provides results for fii (g20210a) and fv leiden (g1691a) mutations to aid in the diagnosis in individuals with suspected thrombophilia.

Australien - Englisch - Department of Health (Therapeutic Goods Administration)

cepheid holdings pty ltd - ct284 - human immunodeficiency virus (hiv) ivds - the hiv-1 vl assay, is an ivd test designed for the rapid quantitation of human immunodeficiency virus type 1 (hiv-1) in human plasma from hiv-1 infected individuals over the range of 40 to 10,000,000 copies/ml, and is validated for specimens across group m subtypes a, b, c, d, ae, f, g, h, ab, ag, j, k and group n and group o.

Australien - Englisch - Department of Health (Therapeutic Goods Administration)

cepheid holdings pty ltd - ct797 - staphylococcus ivds - the xpert mrsa/sa assays are qualitative tests intended for the detection of staphylococcus aureus (sa) and methicillin-resistant staphylococcus aureus (mrsa) from skin and soft tissue infection swabs, patients with positive blood cultures, or nasal swabs in patients at risk for nasal colonization. the test utilizes real time pcr to detect mrsa/sa dna.

Australien - Englisch - Department of Health (Therapeutic Goods Administration)

cepheid holdings pty ltd - ct936 - specimen receptacle ivds - the xpert nasopharyngeal sample collection kit and xpert nasal sample collection kit are designed to collect, preserve, and transport specimens containing viruses from patients with signs and symptoms of respiratory infection.

Australien - Englisch - Department of Health (Therapeutic Goods Administration)

cepheid holdings pty ltd - ct929 - acquired genetic alteration ivds - the xpert bcr-abl monitor and ultra assays are real-time rt-pcr (reverse transcription-polymerase chain reaction) assays intended as an aid in the monitoring of the bcr-abl mrna transcript in peripheral blood of patients with chronic myelogenous leukemia (cml).

Australien - Englisch - Department of Health (Therapeutic Goods Administration)

cepheid holdings pty ltd - ct947 - human papilloma virus ivds - the xpert hpv assay is a qualitative in vitro test for the detection of the e6/e7 region of the viral dna genome from high risk human papillomavirus (hpv) in patient specimens. the test carries out multiplexed amplification of target dna by real-time polymerase chain reaction (pcr) of 14 high risk hpv types in a single analysis. xpert hpv specifically identifies types hpv 16 and hpv 18/45 in two distinct detection channels, and reports 11 other high risk types (31, 33, 35, 39, 51, 52, 56, 58, 59, 66 and 68) in a pooled result. specimens are limited to cervical cells collected in preservcyt? solution (hologic corp.). cervical specimens collected in preservcyt solution that have been pretreated with glacial acetic acid (gaa) to lyse excess red blood cells for cytology review have also been validated for use with the xpert hpv assay.

Australien - Englisch - Department of Health (Therapeutic Goods Administration)

cepheid holdings pty ltd - ct797 - staphylococcus ivds - the xpert mrsa and mrsa nxg, is a qualitative ivd for the detection of methicillin-resistant s. aureus dna from nasal swabs. the test utilizes automated real-time pcr for the amplification of mrsa specific dna targets. the xpert mrsa and mrsa nxg is intended to aid in the prevention and control of mrsa infections in healthcare settings. the xpert mrsa and mrsa nxg are not intended to diagnose, guide, or monitor treatment for mrsa infections, or provide results of susceptibility to methicillin