OCB

Rt-Pcr Multigene Expression Test, Sentinel Lymph Node, Cancer Metastasis Detection

产品代码

OCB

器械名称

Rt-Pcr Multigene Expression Test, Sentinel Lymph Node, Cancer Metastasis Detection

管理类别

第 3 类（Class III）

FDA 专业组

Unknown

上市路径

需 PMA 上市前批准

标记

属生命支持/维持器械

FDA 分类定义

A gene expression test for detection of cancer metastasisis an in vitro diagnostic test performed on tissue of interest from patients previously diagnosed with cancer. Results from the test can be used to guide the intra-operative or post-operative decision to remove additional tissue. Post-operative histological evaluation of permanent sections of the tissue specimen, in accordance with usual diagnostic practice and using an appropriate histological sampling scheme, is required.

定义原文来自 FDA 器械分类库，属美国联邦政府作品（公有领域）。