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

pocratis medical pty ltd - 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

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

qiagen pty ltd - ct772 - severe acute respiratory syndrome-associated coronavirus ivds - ivds for the qualitative detection of sars-cov-2 coronavirus rna from human clinical specimens

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

ljcj pty ltd - ct772 - severe acute respiratory syndrome-associated coronavirus ivds - this kit is used for in vitro qualitative detection of novel coronavirus (covid-19) igm / igg antibodies in human serum, plasma, and whole blood samples. it is only used as a supplementary indicator for suspected cases negative for novel corona virus detection or used in conjunction with nucleic acid detection in the diagnosis of suspected cases. the test results can not be the only basis for diagnosis or exclusion of the coronavirus caused pneumonia. the detection kit is not applicable to general population screening.

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

perkinelmer - ct772 - severe acute respiratory syndrome-associated coronavirus ivds - the assays are intended for the qualitative detection of sars-cov-2 nucleic acids or antibodies as an aid in diagnosing patients suspected of covid-19 or with an adaptive immune response to sars-cov2.

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

pantonic 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). this artg entry also includes ivd medical devices of the kind supplied for accredited laboratory use.

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

vela diagnostics australia pty ltd - ct772 - severe acute respiratory syndrome-associated coronavirus ivds - the virokey? sars-cov-2 rt-pcr test v2.0 is a real-time rt-pcr based in vitro diagnostic test intended for the qualitative detection of rna from sars-cov-2 in nasopharyngeal and oropharyngeal swabs from individuals suspected of covid-19 by their healthcare provider. the virokey? sars-cov-2 rt-pcr test v2.0 is configured for use on the sentosa? sx101 instrument, with the virokey? sx virus total nucleic acid kit or the sentosa? sx virus total nucleic acid kit v2.0, in conjunction with sentosa? sa201 real-time pcr system or the applied biosystems? 7500 fast dx real-time pcr system. results are for the identification of sars-cov-2 rna. the sars-cov-2 rna is generally detectable in nasopharyngeal and oropharyngeal swabs during the acute phase of infection. positive results are indicative of the presence of sars-cov-2 rna; clinical correlation with patient history and other diagnostic information is necessary to determine patient infection status. positive results do not rule out bacterial infection or co-infection with other viruses. the agent detected may not be the definite cause of disease. negative results do not preclude sars-cov-2 infection and should not be used as the sole basis for patient management decisions. negative results must be combined with clinical observations, patient history, and epidemiological information.

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

diasorin australia pty ltd - ct772 - severe acute respiratory syndrome-associated coronavirus ivds - ivds intended for the in vitro qualitative detection of severe acute respiratory syndrome coronavirus 2 (sars-cov-2) viral rna.

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

diasorin australia pty ltd - ct772 - severe acute respiratory syndrome-associated coronavirus ivds - ivds that use chemiluminescence immunoassay (clia) technology for the determination of specific antibodies to sars-cov-2 in human serum or plasma.

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

siemens healthcare pty ltd - ct772 - severe acute respiratory syndrome-associated coronavirus ivds - the dimension exl and dimension vista assays are for in vitro diagnostic use in the qualitative and semi-quantitative detection of antibodies to sars-cov-2 in human serum and plasma (edta and lithium heparin). it is intended as an aid in the diagnosis of patients with suspected sars-cov-2 infection and as an aid in identifying patients with an adaptive immune response to sars-cov-2, indicating recent or prior infection.

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

abbott australasia pty ltd diagnostic division - ct772 - severe acute respiratory syndrome-associated coronavirus ivds - the sars-cov-2 igg/igm assays are chemiluminescent microparticle immunoassays (cmia) used for the qualitative, semi-quantitative and quantitative detection of igg antibodies and qualitative detection of igm antibodies to sars-cov-2 in human clinical specimens.