Device Category Dossier

CT1056 - Immunohistology cell marker IVDs

Device Category Dossier for CT1056 - Immunohistology cell marker IVDs. Australian ARTG records, sponsors, device class — compiled by arcimedes.

Immunohistology cell marker in vitro diagnostic devices are intended to be used in histology and cytology to provide information about the presence and localisation of specific proteins and antigens present in histological tissue sections, cytological smears and fluids. These assays are indicated as aids in identifying patients with various cancers—including epithelial ovarian, fallopian tube, primary peritoneal, gastric, and endometrial carcinoma—who may be eligible for specific targeted or immunotherapeutic treatments in accordance with approved therapeutic product labelling.