Standard No.:	YY/T 1820-2021
English Name:	Specific antinuclear antibody IgG detecting kit (immunoblotting)
Chinese Name:	特异性抗核抗体IgG检测试剂盒（免疫印迹法）
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:	National Medical Products Adminstration
Issued on:	2021-12-06
Implemented on:	2023-5-1
Status:	valid
Target Language:	English
File Format:	PDF
Word Count:	4000 words
Translation Price(USD):	120.0
Delivery:	via email in 1~3 business day

本标准规定了特异性抗核抗体IgG检测试剂盒（免疫印迹法）的要求、试验方法、标识、标签、使用说明书、包装、运输和贮存。
本标准适用于以免疫印迹法为原理的定性检测人血清或血浆中针对细胞核与细胞浆特定靶抗原的抗核抗体特异性自身抗体IgG的试剂盒，包括手工操作法和仪器自动操作法产品。
本标准不适用于抗核抗体总抗体的检测试剂盒。