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

hologic (australia & new zealand) pty ltd - 36122 - hysteroscopic irrigation/distention system - the fluent? fluid management system is intended to provide liquid distension of the uterus during diagnostic and operative hysteroscopy, and to monitor the volume differential between the irrigation fluid flowing into and out of the uterus. the fluent fluid management system is designed to be used in operating room, ambulatory surgical center, and physician?s office environments.

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

hologic (australia & new zealand) pty ltd - ct772 - severe acute respiratory syndrome-associated coronavirus ivds - the panther fusion sars-cov-2 assay is a real-time pcr in vitro diagnostic tests intended for the rapid and presumptive qualitative detection of rna from the sarscov-2 isolated and purified from nasopharyngeal (np) and oropharyngeal (op) swab specimens obtained from individuals meeting department of health sars-cov-2 criteria for sarscov-2 testing.

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

hologic (australia & new zealand) pty ltd - 63474 - hysteroscopy cervical leakage sheath - a sterile tubular cover designed to be fitted on the invasive distal end of a hysteroscope during a hysteroscopic procedure to minimize liquid distention media leakage from the cervix.

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

hologic (australia & new zealand) pty ltd - ct772 - severe acute respiratory syndrome-associated coronavirus ivds - the aptima? sars-cov-2 assay is a nucleic acid amplification test intended for the qualitative detection of rna from sars-cov-2 isolated and purified from nasopharyngeal, nasal, mid-turbinate and oropharyngeal swab specimens, nasopharyngeal wash/aspirate or nasal aspirates obtained from individuals meeting covid-19 clinical and/or epidemiological criteria, as well as upper respiratory specimens collected from any individual, including individuals without symptoms. this test is also for the detection of sars-cov-2 in pooled samples containing up to 5 individual upper respiratory swab specimens where each specimen is collected under observation or by a healthcare provider using individual vials containing transport media.

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

hologic (australia & new zealand) pty ltd - ct936 - specimen receptacle ivds - specimen collection kit containing a sterile polyester-tipped swab and specimen transport tube for the collection of cervicovaginal specimens for the rapid ffn 10q system.

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

hologic (australia & new zealand) pty ltd - 60650 - endoscope working-channel seal - accessory to hysteroscopes and are used to prevent fluid leakage from the proximal end of the removable outflow channels.

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

hologic (australia & new zealand) pty ltd - ct748 - cytomegalovirus (human herpesvirus 5) ivds - the aptima cmv quant assay is an in vitro nucleic acid amplification test for the quantitation of human cytomegalovirus dna in human edta plasma and whole blood on the fully automated panther system. the aptima cmv quant assay is intended for use to aid in the diagnosis and to aid in the management of solid-organ transplant patients and hematopoietic stem cell transplant patients.

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

hologic (australia & new zealand) pty ltd - ct974 - clinical chemistry-specific protein ivds - the rapid ffn test is for the detection of fetal fibronectin in cervicovaginal secretions in samples collected from pregnant women to aid in assessment of the risk of preterm delivery. the rapid ffn test is a point of care test.

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

hologic (australia & new zealand) pty ltd - ct943 - instrument/analyser ivds - the perilynx system is an in vitro diagnostic device intended to be used in conjunction with the rapid ffn 10q cassette, the rapid ffn control kit, and the perilynx qcette for the detection of fetal fibronectin (ffn) in cervicovaginal secretions. the perilynx system is a point of care device.

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

hologic (australia & new zealand) pty ltd - ct1250 - analyser software ivds - software that is intended to be incorporated into an ivd analyser (e.g. processor, imager, review station) to establish or supplement operational functions which may include the processing of specimens, generation of data, interpretation, storage, display and/or reporting of results obtained from a clinical laboratory specimen.