Austraalia - inglise - Department of Health (Therapeutic Goods Administration)

accelagen pty ltd - ct772 - severe acute respiratory syndrome-associated coronavirus ivds - resolute 2.0 is a real-time rt-pcr test intended for the qualitative detection of nucleic acid from the sars-cov-2 virus in nasopharyngeal swabs specimen from individuals with signs and symptoms of infection who are suspected of covid-19.

Austraalia - inglise - Department of Health (Therapeutic Goods Administration)

haemokinesis limited - ct772 - severe acute respiratory syndrome-associated coronavirus ivds - for the qualitative detection of sars-cov-2 antigen from nasopharyngeal swab specimen

Austraalia - inglise - Department of Health (Therapeutic Goods Administration)

am diagnostics - 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 (nasopharyngeal swabs, nasal swabs and oral fluid) and for self-testing by lay persons (nasal swabs and oral fluid).

Austraalia - inglise - Department of Health (Therapeutic Goods Administration)

emergo asia pacific pty ltd t/a emergo australia - ct772 - severe acute respiratory syndrome-associated coronavirus ivds - wondfo 2019-ncov antigen test (lateral flow method) is animmunochromatographic assay for rapid, qualitative detectionof novel coronaviruses (2019-ncov) antigen extracted fromthe nasopharyngeal swab or oropharyngeal swab specimen.the test is to be used as an aid in the diagnosis ofcoronavirus infection disease (covid-19), which is caused by2019-ncov. the test provides preliminary test results.negative results cannot exclude 2019-ncov infection andthey cannot be used as the sole basis for treatment or othermanagement decision. for in vitro diagnostic use only. forprofessional use only.

Austraalia - inglise - Department of Health (Therapeutic Goods Administration)

australia health products central 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 for point of care testing (nasopharyngeal swab and nasal swab) and self-testing by lay persons (nasal swabs)

Austraalia - inglise - Department of Health (Therapeutic Goods Administration)

eurofins technologies australia 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 (nasopharyngeal and nasal swabs) and for self-testing by lay persons (nasal swabs).

Austraalia - inglise - Department of Health (Therapeutic Goods Administration)

pharma soul pty ltd - ct772 - severe acute respiratory syndrome-associated coronavirus ivds - the pixotest? covid-19 ag test kit is a rapid chromatographic immunoassay for the qualitative detection of sars-cov-2 present in human nasopharynx cavity. the pixotest? covid-19 ag test kit is designed to be used in conjunction with the pixotest? poct analyser for the issuing of fully digitalised rapid sars-cov-2 test results. this test is single use only and the administration of the test and the interpretation of the results should be done by trained healthcare professionals only. the result of this test should not be the sole basis for the diagnosis of covid-19; additional confirmatory testing is required.

Austraalia - inglise - Department of Health (Therapeutic Goods Administration)

compliance management solutions - 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 (nasal swabs, oral fluid) and for self-testing by lay persons (nasal swabs, oral fluid).

Austraalia - inglise - Department of Health (Therapeutic Goods Administration)

2san 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 (nasal swabs) and for self-testing by lay persons (nasal swabs)

Austraalia - inglise - Department of Health (Therapeutic Goods Administration)

cole supplies 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 (saliva samples) and for self-testing by lay persons (saliva samples)