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

leica biosystems melbourne pty ltd - ct943 - instrument/analyser ivds - instruments for preparing pathology samples, including tissue samples, for diagnosis by a pathologist.

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

leica biosystems melbourne pty ltd - ct907 - histology and cytology ancillary ivds - ihc and ish ancillary reagents and kits for use with ihc/ish tests.

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

leica biosystems melbourne pty ltd - ct929 - acquired genetic alteration ivds - for the qualitative detection of; a) her2 (human epidermal growth factor receptor 2) oncoprotein status via immunohistochemistry or b) amplification of her2/neu gene via fluorescence in situ hybridization (fish) in formalin-fixed, paraffin-embedded human breast cancer tissue specimens. as an aid in the assessment of patients for whom herceptin?* (trastuzumab) treatment is being considered

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

leica biosystems melbourne pty ltd - ct353 - bacterial infectious disease ivds - for used in testing tissue to provide information about infection with or exposure to one or a number of bacterial diseases.

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

leica biosystems melbourne pty ltd - ct945 - general laboratoryware ivds - reagents intended to be used in histology with in vitro diagnostic tests.

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

leica biosystems melbourne pty ltd - ct907 - histology and cytology ancillary ivds - tissue marking and margin dyes are used to microscopically identify specific areas of tissue specimens that have diagnsotic importance, for identification and orientation of excised surgical specimens, and for the method of marking of skin tissue when utilising moh's techniques

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

leica biosystems melbourne pty ltd - ct1056 - immunohistology cell marker ivds - the antibodies are intended to be used for the qualitative identification by light microscopy of cell markers in formalin-fixed, paraffin-embedded tissue by immunohistochemical staining.

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

leica biosystems melbourne pty ltd - ct943 - instrument/analyser ivds - instrument for processing tissue in a laboratory in preparation for further tests and diagnosis by a pathologist.

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

leica biosystems melbourne pty ltd - ct355 - viral infectious disease ivds - for used in testing tissue to provide information about infection with or exposure to one or a number of viral diseases.

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

leica biosystems melbourne pty ltd - ct910 - interpretive software ivds - software applications for the analysis and visualization of human genome data.