关于Cytognos产品的使用标注说明

2021/06/24 admin

产品标注的使用范围如下:

“RUO” or “For Research Use Only”: not intended for diagnostic or therapeutic procedures.
“CE-IVD”: products intended for in vitro diagnostic use and conforming to European Directive (98/79/EC).
“LUO” or “Laboratory Use Only”: general purpose laboratory reagents.
“ASR” or “Analyte Specific Reagent”: reagents in which the analytical and performance characteristics are not established. ASRs are regulated by the US Food and Drug Administration (FDA).


RUO:仅供科研

CE-IVD:用于体外诊断并符合欧洲指令 (98/79/EC) 的产品。

LUO:Laboratory Use Only,通用实验室试剂。

ASR:Analyte Specific Reagent,未建立分析和性能特征的试剂。ASR 受美国食品和药物管理局 (FDA) 监管。