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

beckman coulter australia pty ltd - ct772 - severe acute respiratory syndrome-associated coronavirus ivds - the access sars-cov-2 igg assay is a paramagnetic particle, chemiluminescent immunoassay intended for the qualitative detection of igg antibodies to sars-cov-2 in serum, serum separator tubes and plasma (edta, citrate and heparin) from individuals with current or prior covid-19 infection. kit, calibrators and qc.

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

roche diagnostics australia pty limited - 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 controls) and for self-testing by lay persons (nasal swabs).

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

ha tech pty ltd - ct772 - severe acute respiratory syndrome-associated coronavirus ivds - detection of covid-19 in diagnostic specimens: the detection assay is a real-time rt-pcr test is only used for 2019 novel coronavirus (sars-cov-2) nucleic acid detection. results are for the identification of sars-cov-2 rna. the rt-pcr test is intended for the qualitative detection of nucleic acid from the sars-cov-2 in the upper respiratory specimens such as nasopharyngeal swabs and oropharyngeal swabs. the real-time rt-pcr test is intended for use by qualified clinical laboratory personnel specifically trained in the techniques of real-time pcr and in vitro diagnostic procedures.

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

nature's family australia pty ltd - ct772 - severe acute respiratory syndrome-associated coronavirus ivds - genbody covid-19 ag kit is an immunochromatographic assay for the qualitative detection of sars-cov-2 antigen in nasopharyngeal and oropharyngeal swab from human

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

stonestar wholesale 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 swab, throat swab) and for self-testing by lay persons (anterior nasal swab).

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

cartex hoya pty ltd - ct772 - severe acute respiratory syndrome-associated coronavirus ivds - the biotime sars cov-2 igg/igm rapid qualitative test is intended to be used to qualify the presence of sars cov-2 igg and igm antibodies in human plasma, serum or whole blood by colloidal gold immunochromatography assay. the test can be used as an aid for detection of the sars cov-2 infection and is a useful screening tool to assist with challenges in identifying covid-19 cases. this test is for in vitro diagnostic use only and for use by professionals only.

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

atomo diagnostics limited - ct772 - severe acute respiratory syndrome-associated coronavirus ivds - the atomo covid-19 anigen test is a lateral flow immunochromatographic assay intended for the qualitative detection of the nucleocapsid protein antigen from sars-cov-2 in nasopharyngeal or anterior nasal swab specimens directly collected from individuals who are either suspected of covid-19 by their healthcare provider within first five days of symptom onset. this test is intended for use at the point of care (poc). results are for the identification of the sars-cov-2 nucleocapsid protein antigen. the antigen is generally detectable in nasopharyngeal or anterior nasal swab specimens during the acute phase of infection. positive results indicate the presence of viral antigens, but the clinical correlation with patient history and other diagnostic information is necessary to determine infection status. positive results do not rule out a bacterial infection or co-infection with other viruses. the agent detected may not be the definite cause of disease. laboratories are required to report all positive results to

Euroopa Liit - inglise - EMA (European Medicines Agency)

intervet international b.v. - cell-associated live recombinant turkey herpesvirus (strain hvt/ndv/ilt) expressing the fusion protein of newcastle disease virus and the glycoproteins gd and gi of infectious laryngotracheitis virus - immunologicals for aves - embryonated chicken eggs; chicken - for active immunisation of one-day-old chicks or embryonated chicken eggs:to reduce mortality and clinical signs caused by newcastle disease (nd) virus,to reduce mortality, clinical signs and lesions caused by avian infectious laryngotracheitis (ilt) virus and marek’s disease (md) virus.

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

rachael flood - ct772 - severe acute respiratory syndrome-associated coronavirus ivds - the covid-19 real-time pcr kit (hbrt-covid-19) is designed for the qualitative detection of nucleic acids from sars-cov-2 in oropharyngeal swab and nasopharyngeal swab specimen from patients who meet covid-19 clinical and/or epidemiological criteria.

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

health vision australasia pty ltd - ct772 - severe acute respiratory syndrome-associated coronavirus ivds - the arista? covid-19 antigen rapid test is for the qualitative in vitro detection of the sars-cov-2 virus nucleocapsid (n)-protein antigen in anterior nasal and nasopharyngeal swab specimens.