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微生物学设备；直接用于临床标本的流感病毒抗原检测测试系统的重新分类。最终命令。

Microbiology Devices; Reclassification of Influenza Virus Antigen Detection Test Systems Intended for Use Directly With Clinical Specimens. Final order.

出版信息

Fed Regist. 2017 Jan 12;82(8):3609-19.

PMID:28102980
Abstract

The Food and Drug Administration (FDA) is reclassifying antigen based rapid influenza virus antigen detection test systems intended to detect influenza virus directly from clinical specimens that are currently regulated as influenza virus serological reagents from class I into class II with special controls and into a new device classification regulation.

摘要

美国食品药品监督管理局（FDA）正在将基于抗原的快速流感病毒抗原检测系统重新分类，该系统旨在直接从临床标本中检测流感病毒，目前作为流感病毒血清学试剂按I类进行监管，现重新分类为II类并实施特殊控制，同时归入一项新的器械分类规定。

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