Standard No.:	YY/T 1611-2018
English Name:	Human immunodeficiency virus antibodies detection kits(Immuno-chromatography)
Chinese Name:	人类免疫缺陷病毒抗体检测试剂盒（免疫层析法）
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
Issued by:	National Medical Products Adminstration
Issued on:	2018-12-20
Implemented on:	2020-1-1
Status:	valid
Language:	English
File Format:	PDF
Word Count:	7500 words
Price(USD):	110.00
Delivery:	via email in 1~3 business day

本标准规定了人类免疫缺陷病毒抗体检测试剂盒（免疫层析法）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层析法为原理，对人血清或血浆中的人类免疫缺陷病毒(human immunodeficiency virus,HIV)1型和2型（HIV-1/2）抗体进行定性检测的胶体金法、胶体硒法、免疫层析法、乳胶层析法等人类免疫缺陷病毒抗体检测试剂盒。