PIV

Automated Indirect Immunofluorescence Microscope And Software-Assisted System For Clinical Use

产品代码: PIV
器械名称: Automated Indirect Immunofluorescence Microscope And Software-Assisted System For Clinical Use
管理类别: 第 2 类（Class II）
21 CFR 条款: 21 CFR 866.4750
FDA 专业组: Immunology
上市路径: 需提交 510(k) 上市前通告
标记: 可走第三方审查
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

Automated system consisting of a fluorescence microscope and software that acquires, analyzes, stores and displays digital images of stained indirect immunofluorescent slides. It is intended as an aid in the detection and classification of certain antibodies by indirect immunofluorescent technology. A trained operator must confirm all device generated results.

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）。

FDA 官方分类页： PIV

分类与上市路径以 FDA 现行公告为准。本页数据来自 openFDA（CC0 公有领域），不构成注册策略建议。