Standard No.:	YY/T 1918-2023
English Name:	Digital polymerase chain reaction analysis system
Chinese Name:	数字聚合酶链反应分析系统
Chinese Classification:	C44    Medical laboratory equipment
Professional Classification:	YY    Professional Standard - Pharmaceutics
ICS Classification:	11.100.10 11.100.10    In vitro diagnostic test systems 11.100.10
Issued by:	National Medical Products Adminstration
Issued on:	2023-09-05
Implemented on:	2024-9-15
Status:	valid
Language:	English
File Format:	PDF
Word Count:	7500 words
Price(USD):	210.00
Delivery:	via email in 1~3 business day

本文件规定了数字聚合酶链反应分析系统的分类，要求，试验方法，标签、标识和使用说明，包装、运输和贮存等内容。
本文件适用于对核酸样本以单液滴或单核酸分子方式生成数百个至数百万个独立反应单元的设备，分析系统包括微液滴生成模块、聚合酶链反应模块和微滴检测模块等。