NYI

Classifier, Prognostic, Recurrence Risk Assessment, Rna Gene Expression, Breast Cancer

产品代码

NYI

器械名称

Classifier, Prognostic, Recurrence Risk Assessment, Rna Gene Expression, Breast Cancer

管理类别

第 2 类（Class II）

21 CFR 条款

21 CFR 866.6040

FDA 专业组

Immunology

上市路径

需提交 510(k) 上市前通告

FDA 历史累计 510(k)

10 件（全部年份；本站只收录近三年的明细）

FDA 分类定义

A device which uses a gene expression profile of a breast cancer tumor, from patients stage i or stage ii lymph node negative, with a tumor size of <5.0 cm, to provide a risk assessment for distant recurrence of breast cancer. The result is indicated for use only as a prognostic marker by physicians along with a number of other factors to assess the risk of recurrence of breast cancer.

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）。