QDC

Dna-Based Test For Minimal Residual Disease For Hematologic Malignancies

产品代码

QDC

器械名称

Dna-Based Test For Minimal Residual Disease For Hematologic Malignancies

管理类别

第 2 类（Class II）

21 CFR 条款

21 CFR 866.6100

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)

2 件

FDA 分类定义

A DNA-based test for minimal residual disease is an in vitro diagnostic device that identifies and quantifies specific nucleic acid sequences isolated from human specimens to estimate the percentage of cells that harbor the specific sequence(s). The test is intended to be used as an aid to measure minimal residual disease to monitor the change in burden of disease for patients with a hematological malignancy during and after treatment. The results should be interpreted by a pathologist or equivalent professional in conjunction with other clinical and laboratory findings.

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）。