SBY

High Throughput Sequencing Based Tumor Profiling Test Of Circulating Cell-Free Nucleic Acids

产品代码

SBY

器械名称

High Throughput Sequencing Based Tumor Profiling Test Of Circulating Cell-Free Nucleic Acids

管理类别

第 2 类（Class II）

21 CFR 条款

21 CFR 866.6085

FDA 专业组

Pathology

上市路径

需提交 510(k) 上市前通告

该代码近三年的 510(k)

1 件

FDA 分类定义

A high throughput sequencing based tumor profiling test of circulating cell-free nucleic acids is a qualitative in vitro diagnostic test intended for next generation sequencing analysis of circulating cell-free nucleic acids from plasma samples collected from peripheral whole blood to detect mutations in a panel of targeted genes to aid in the management of previously diagnosed cancer patients by qualified health care professionals. The results of the test are not prescriptive or conclusive for use of any specific therapeutic product.

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）。

该代码近三年的 510(k)（1 件）

数据窗口为最近三年。最新一件：2024-08-01。