NXG

Fluorescence In Situ Hybridization, Topoisomerase Ii Alpha, Gene Amplification And Deletion

产品代码

NXG

器械名称

Fluorescence In Situ Hybridization, Topoisomerase Ii Alpha, Gene Amplification And Deletion

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

FDA 分类定义

Topoisomerase ii alpha (top2a) fluorescence in situ hybridization (fish) kit is to detect the top2a gene copy number changes (amplification and deletion) in breast cancer using formalin-fixed, paraffin-embeded human breast cancer tissue specimen.

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）。