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医疗器械；免疫学和微生物学器械；登革热病毒核酸扩增检测试剂分类。最终命令。

Medical devices; immunology and microbiology devices; classification of dengue virus nucleic acid amplification test reagents. Final order.

出版信息

Fed Regist. 2014 Sep 10;79(175):53608-9.

PMID:25233532
Abstract

The Food and Drug Administration (FDA) is classifying dengue virus nucleic acid amplification test reagents into class II (special controls). The Agency is classifying the device into class II (special controls) because special controls, in addition to general controls, will provide a reasonable assurance of safety and effectiveness of the device.

摘要

美国食品药品监督管理局（FDA）正在将登革热病毒核酸扩增检测试剂归类为II类（特殊控制）。该机构将该设备归类为II类（特殊控制），是因为除一般控制外，特殊控制将为该设备的安全性和有效性提供合理保证。

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