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

hologic (australia & new zealand) pty ltd - 37646 - x-ray system, diagnostic, fluoroscopic, general-purpose, mobile, digital - intended to be used to general purpose diagnostic fluroscopic x-ray used to capture real time image capture and display.

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

hologic (australia & new zealand) pty ltd - 57812 - radiology dicom image processing application software - intended to be used in conjunction with picture archiving and communication systems to produce various image configurations and including 3d images. will store and retrieve images and mark regions of interest.

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

hologic (australia & new zealand) pty ltd - 41972 - hepatitis c virus total antibody ivd, calibrator - aptima hcv quant dx calibrators are intended to calibrate the aptima hcv quant dx assay for the qualitative detection of antibodies to hcv in human serum and plasma. aptima hcv quant dx calibrators are intended to calibrate the aptima hcv quant dx assay for the qualitative detection of antibodies to hcv in human serum and plasma.

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

hologic (australia & new zealand) pty ltd - 41973 - hepatitis c virus total antibody ivd, control - aptima hcv quant dx control kit monitors the performance of the aptima hcv quant dx assay aptima hcv quant dx control kit is intended for monitoring system performance of the aptima hcv quant dx assay.

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

hologic (australia & new zealand) pty ltd - 48374 - hepatitis c virus nucleic acid ivd, kit, nucleic acid technique (nat) - the aptima hcv quant dx assay is a real-time transcription-mediated amplification test. this assay is used for both detection and quantitation of hepatitis c virus (hcv) rna in fresh and frozen human serum and plasma from hcv-infected individuals. the aptima hcv quant dx assay is indicated as an aid in the diagnosis of hcv infection. the assay confirms active hcv infection in patients with a positive hcv antibody result. detection of hcv rna indicates that the virus is replicating and therefore is evidence of active infection.the aptima hcv quant dx assay is also indicated as an aid in the management of hcv infected patients undergoing hcv antiviral drug therapy. the results from the aptima hcv quant dx assay must be interpreted within the context of all relevant clinical and laboratory findings. specimens containing hcv genotypes 1 to 6 are validated for detection and quantitation in the assay.

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

hologic (australia & new zealand) pty ltd - 36190 - stereotactic biopsy system, diagnostic x-ray, mammography - its function is to localise lesions accurately in the breast in three dimensions. it is intended to provide targeting guidance for interventional procedures such as biopsy, pre-surgical localisation, or treatment devices.

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

hologic (australia & new zealand) pty ltd - 41670 - radiology picture archiving and communication system application software - intended to be used in conjunction with picture archiving and communications systems to produce various image configurations including 3d images. it is capable of retrieving prior mammography images for display from pacs and other dicom image storage systems.

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

hologic (australia & new zealand) pty ltd - 46435 - uterine sound, single-use - the device is a uterine sound intended to measure the uterine cavity length and cervical canal length.

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

hologic (australia & new zealand) pty ltd - ct943 - instrument/analyser ivds - instrument/analyser ivds manual, semi-automated or automated equipment or apparatus intended to be used as an in vitro diagnostic medical device for the purposes of processing, examining and/or providing information about a clinical specimen.

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

hologic (australia & new zealand) pty ltd - ct944 - software ivds - ivd software for the collection, interpretation, reporting, input, storage or retrieval of digital data or other information.