DevicePMAs@therightstef:P060017_S000 JSONTXT 13 Projects

Approval for the genesearch breast lymph node (bln) assay. this device is indicated as a qualitative, in vitro diagnostic test for the rapid detection of greater than 0.2 mm metastases in nodal tissue removed from sentinel lymph node biopsies of breast cancer patients. results from the assay can be used to guide the intra operative or post-operative decision to remove additional lymph nodes. post-operative histological evaluation of permanent sections of the tissue specimen, in accordance with usual diagnostic practice and using the veridex lymph node cutting scheme, is required.