QGN

Lateral Flow Immunochromatography Assay For Host Infection Biomarkers

产品代码

QGN

器械名称

Lateral Flow Immunochromatography Assay For Host Infection Biomarkers

管理类别

第 2 类（Class II）

21 CFR 条款

21 CFR 866.3230

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)

2 件（全部年份；本站只收录近三年的明细）

FDA 分类定义

A device to detect and measure non-microbial analytes to aid in the detection and identification of localized human infections is identified as an in vitro device intended for the detection and qualitative measurement, quantitative measurement, or both of one or more non-microbial analytes in human clinical specimens to aid in the assessment, identification, or both of a localized microbial infection when used in conjunction with clinical signs and symptoms and 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）。