OMG

Antisera, Fluorescent, Human Metapneumovirus

产品代码

OMG

器械名称

Antisera, Fluorescent, Human Metapneumovirus

管理类别

第 2 类（Class II）

21 CFR 条款

21 CFR 866.3980

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)

4 件（全部年份；本站只收录近三年的明细）

FDA 分类定义

It is intended for the qualitative detection and identification of human metapneumovirus (hMPV) in direct respiratory specimens or cell culture. The assay detects hMPV antigens by immunofluorescence using antibodies, from patients with signs and symptoms of acute respiratory infection. This assay detects but is not intended to differentiate the four recognized genetic sub-lineages of hMPV.

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）。