Standard No.:	YY/T 1592-2018
English Name:	ABO forward blood grouping and RhD typing reagents(column agglutination technique,CAT)
Chinese Name:	ABO正定型和RhD血型定型检测卡（柱凝集法）
Chinese Classification:	C30    Medical apparatus and devices in general
Professional Classification:	YY    Professional Standard - Pharmaceutics
ICS Classification:	11.040.30 11.040.30    Surgical instruments and materials 11.040.30
Source Content Issued by:	China Food and Drug Adminstration
Issued on:	2018-02-24
Implemented on:	2019-3-1
Status:	valid
Target Language:	English
File Format:	PDF
Word Count:	5500 words
Translation Price(USD):	160.0
Delivery:	via email in 1~3 business day

本标准规定了ABO正定型和RhD血型定型检测卡（柱凝集法）的要求、试验方法、标识、标签、使用说明书、包装、运输和贮存。
本标准适用于使用凝胶、玻璃微珠等材料进行填充微柱，以免疫血液学、颗粒过筛和离心技术三者结合为原理，进行临床红细胞ABO血型系统的正定型鉴定和Rh系统中正常D抗原的检测。
本标准不适用于血源筛查进行ABO正定型和RhD血型鉴别的诊断试剂。