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

hologic (australia & new zealand) pty ltd - 40926 - x-ray compression device, mammography - this is an accessory to a mammographic x-ray system. it is a paddle intended to compress the breast tissue in order for an x-ray image to be taken, when attached to a mammography machine.

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

hologic (australia & new zealand) pty ltd - 60437 - interventional radiology percutaneous-access procedure kit - intended to be used for image-guided breast biopsy procedure to provide access to the biopsy site for the biopsy needle.

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

hologic (australia & new zealand) pty ltd - ct702 - multiple-viruses ivds - the panther fusion sars-cov-2/flu a/b/rsv assay is a multiplex real-time pcr (rt-pcr) in vitro diagnostic test for the rapid and qualitative detection and differentiation of sars-cov-2, influenza a virus, influenza b virus, and respiratory syncytial virus (rsv). nucleic acids are isolated and purified from nasopharyngeal (np) swab specimens obtained from individuals exhibiting signs and symptoms of a respiratory tract infection.

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

hologic (australia & new zealand) pty ltd - 44087 - information system software, application program, radiology - to better integrate the workflow of the entire radiology department. it is server software intended to satisfy a number of tasks specific to mammography workflow.

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

hologic (australia & new zealand) pty ltd - 36190 - stereotactic biopsy system, diagnostic x-ray, mammography - intended to provide breast tissue samples for diagnostic sampling of breast abnormalities. the system excises targeted tissue and optionally delivers in-line radiographic images of the excised tissue.

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

hologic (australia & new zealand) pty ltd - 62059 - suction system filter, tissue, sterile - a sterile device intended to be fitted into a suction system canister to separate tissue from the aspirate during a surgical procedure; the tissue may be subsequently used for histological analysis.

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

hologic (australia & new zealand) pty ltd - ct353 - bacterial infectious disease ivds - the aptima? bv assay is an in vitro nucleic acid amplification test that utilizes real time transcription-mediated amplification (tma) for detection and quantitation of ribosomal rna from bacteria associated with bacterial vaginosis (bv), including lactobacillus (l. gasseri, l. crispatus, and l. jensenii), gardnerella vaginalis, and atopobium vaginae. the assay reports a qualitative result for bv and does not report results for individual organisms. the assay is intended to aid in the diagnosis of bv on the automated panther? system using clinician-collected and patient-collected vaginal swab specimens from females with a clinical presentation consistent with vaginitis and/or vaginosis.

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

hologic (australia & new zealand) pty ltd - ct923 - multiple infectious organism ivds - the aptima? cv/tv assay is an in vitro nucleic acid amplification test for the detection of rna from microorganisms associated with vaginitis, trichomoniasis, and vulvovaginitis. the assay utilizes real time transcription-mediated amplification (tma) to detect and qualitatively report results for the following organisms: candida species group (c. albicans, c. tropicalis, c. parapsilosis, c. dubliniensis), candida glabrata, trichomonas vaginalis. the assay is intended to aid in the diagnosis of vulvovaginal candidiasis and trichomoniasis on the automated panther? system using clinician-collected and patient-collected vaginal swab specimens from females with a clinical presentation consistent with vaginitis, trichomoniasis, and/or vulvovaginitis.

Australia - engelsk - 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.