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

bgi health (au) company pty ltd - ct772 - severe acute respiratory syndrome-associated coronavirus ivds - tests that are intended to detect the novel coronavirus sars-cov-2 that causes covid-19 at the point of care by trained health professionals (nasopharyngeal and oropharyngeal swabs), by lay person self-testing (nasal swab), and by qualitative in vitro nucleic acid amplification assay (rt-pcr) by trained professionals.

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

bgi health (au) company 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 swab) and for self-testing by lay persons (nasal swab).

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

bgi health (au) company pty ltd - ct936 - specimen receptacle ivds - a collection kit that is intended to be used for the collection, transportation, and storage of human stool samples.

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

bgi health (au) company pty ltd - ct946 - general laboratory reagent and consumables ivds - for nucleic acid extraction, enrichment, purification and for sample pretreatment for methylation detection. its processed products are used for clinical in vitro and genetic testing.

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

bgi health (au) company pty ltd - ct946 - general laboratory reagent and consumables ivds - for nucleic acid extraction, enrichment, purification and other steps. its processed products are used for clinical in vitro testing.

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

bgi health (au) company pty ltd - ct702 - multiple-viruses ivds - ivds that are intended to be used to detect and differentiate infection due to multiple specified viruses.

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

bgi health (au) company pty ltd - ct826 - constitutional chromosomal disorder ivds - an ivd kit used to perform prenatal screening for trisomies of chromosomes 21, 18 and 13 (t21, t18 and t13) by analyzing the differences in the number of chromosomes 21, 18 and 13 in the cell-free fetal dna in maternal plasma samples. this kit is used to prepare a sequencing dna library of cell free dna.

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

bgi health (au) company pty ltd - ct910 - interpretive software ivds - for screening of fetal aneuploidy using data generated from high-throughput sequencing platforms.

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

bgi health (au) company pty ltd - ct929 - acquired genetic alteration ivds - a noninvasive in vitro diagnostic assay for qualitative detection of sdc2, adhfe1 and ppp2r5c genes methylation isolated from human stool specimens.

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

bgi health (au) company pty ltd - 57940 - nasopharyngeal swab - intended to be used for the collection and transportation of nasal, oral and throat infection virus and other samples.