QPO

Device To Preserve And Stabilize Relative Abundances Of Microbial Nucleic Acids In Clinical Samples

产品代码

QPO

器械名称

Device To Preserve And Stabilize Relative Abundances Of Microbial Nucleic Acids In Clinical Samples

管理类别

第 2 类（Class II）

21 CFR 条款

21 CFR 866.2952

FDA 专业组

Microbiology

上市路径

需提交 510(k) 上市前通告

FDA 历史累计 510(k)

1 件（全部年份；本站只收录近三年的明细）

FDA 分类定义

A device to preserve and stabilize relative abundances of microbial nucleic acids in clinical samples is a device that consists of a container and reagents intended to stabilize microbial nucleic acids for the subsequent assessment of the relative abundance of microbial nucleic acids (i.e., microbiome) in human specimens by an assay validated for use with the device. The device may also be indicated for sample collection. The device is not intended for preserving morphology or viability of microorganisms.

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）。