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

am diagnostics - ct772 - severe acute respiratory syndrome-associated coronavirus ivds - the 2019-n-cov igg/igm rapid test cassette is a lateral flow chromatographic immunoassay for the qualitative detection of igg and igm antibodies to 2019-ncov in human whole blood , serum or plasma specimens

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

apac security pty ltd - ct772 - severe acute respiratory syndrome-associated coronavirus ivds - ?intended to detect the novel coronavirus sars-cov-2 that causes covid-19 from symptomatic individuals at the point of care by trained health professionals (whole blood, serum, plasma, nasopharyngeal swabs and nasal swabs) and for self-testing by lay persons (nasal swabs).?

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

abacus dx pty ltd - ct772 - severe acute respiratory syndrome-associated coronavirus ivds - identification and differentiation of coronavirus (sars-cov-2) in respiratory samples including the 2019 novel covid-19

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

suretest - ct772 - severe acute respiratory syndrome-associated coronavirus ivds - the device is a test kit intended for screening and aiding in the diagnosis of patients who are suspected to be infected with the sars-cov-2 virus.

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

integrated sciences pty ltd - ct772 - severe acute respiratory syndrome-associated coronavirus ivds - detection of covid-19 in diagnostic specimens

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

icon international pty ltd t/a icon medipharm - ct772 - severe acute respiratory syndrome-associated coronavirus ivds - real time multiplex rt pcr kit is used for the qualitative detection of a novel coronavirus, which was identified in 2019

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

md solutions australasia pty ltd - ct772 - severe acute respiratory syndrome-associated coronavirus ivds - intended to detect the novel coronavirus sars-cov-2 that causes covid-19 from symptomatic individuals at the point of care by trained health professionals (whole blood, serum, plasma, nasal swabs, nasopharyngeal swabs) and for self-testing by lay persons (nasal swabs).

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

innovation scientific pty ltd - ct772 - severe acute respiratory syndrome-associated coronavirus ivds - intended to detect the novel coronavirus sars-cov-2 that causes covid-19 from symptomatic individuals at the point of care by trained health professionals (whole blood, serum, plasma, nasal swabs, nasopharyngeal swabs and nasal wash/aspirate) and for self-testing by lay persons with or without symptoms (nasal swabs).

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

emergo asia pacific pty ltd t/a emergo australia - ct772 - severe acute respiratory syndrome-associated coronavirus ivds - covid-19 coronavirus real-time pcr kit is an in vitro diagnostic (ivd) reagent replying on fluorescent pcr technology and aiming at qualitatively detect sars-cov-2 novel coronavirus from upper and lower respiratory tract samples. upper respiratory tract samples include throat swab, nasal swab, and nasopharyngeal extract. lower respiratory tract samples include sputum, respiratory tract extract, bronchial perfusate, and bronchoalveolar lavage fluid. sampling objectives include suspected cases infected by sars-cov-2, suspected cases due to crowd gathering, other cases need to be diagnosed with sars-cov-2, and other suspected environmental and biomaterials (for traceability analysis, for example). sampling should be carried out by well-trained professionals with biosafety and experimental skills. typically sars-cov-2 rna could be detected from upper and lower respiratory tract samples if a person is infected. a positive result suggests sars-cov-2 infection but bacteria and other virus-induced co-infection could not be excluded. sars-cov-2 test result is not the only confirmed evidence of suspected cases and all positive results have to be reported to the centers for disease control (cdcs) and authorities. negative results can neither straightforwardly exclude sars-cov-2 infection and nor the only decision-making evidence for treatment and patient management. a negative result should be appropriately used by combining clinical observation, medical history, and epidemiological information. the test is only available to qualified laboratories, certificated clinical pcr laboratories and 15189 certified third-party laboratories with real-time pcr thermal cyclers. operators carrying out sars-cov-2 nucleic acid testing should be well trained with laboratory biosafety and pcr experimental skills.

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

southwind international pty ltd - ct772 - severe acute respiratory syndrome-associated coronavirus ivds - covid-19 igg/igm rapid test cassette (whole blood/serum/plasma) is a solid phase immunochromatographic assay for the rapid, qualitative and differential detection of igg and igm antibodies to 2019 novel coronavirus in human whole blood, serum or plasma. this test provides only a preliminary test result. therefore, any reactive specimen with the covid-19 igg/igm rapid test cassette (whole blood/serum/plasma) must be confirmed with alternative testing method(s) and clinical findings.for professional in vitro diagnostic use only.?results from antibody testing should not be used as the sole basis to diagnose or exclude sars-cov-2 infection or to inform infection status.