Standard No.:	YY/T 1970-2025
English Name:	Lipoprotein-associated phospholipase A2 testing kit(Chemiluminescent immuoassay)
Chinese Name:	脂蛋白相关磷脂酶A2测定试剂盒（化学发光免疫分析法）
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
Source Content Issued by:	NMPA
Issued on:	2025-06-18
Implemented on:	2026-7-1
Status:	to be valid
Target Language:	English
File Format:	PDF
Word Count:	7500 words
Translation Price(USD):	225.0
Delivery:	via email in 1~3 business day

本文件规定了脂蛋白相关磷脂酶A2测定试剂盒（化学发光免疫分析法）的要求、标识、标签和使用说明、包装、运输和贮存，描述了相应的试验方法。
本文件适用于以化学发光免疫分析法为原理定量测定人血清和血浆脂蛋白相关磷脂酶A2的试剂盒，包括以微孔板、管、磁颗粒、微珠和塑料珠等为载体的化学发光分析测定试剂盒。