Standard No.:	YY 1727-2020
English Name:	Human immunodeficiency virus antibodies in human oral mucosal transudate detecting kits (Colloidal gold immuno-chromatography)
Chinese Name:	口腔黏膜渗出液人类免疫缺陷病毒抗体检测试剂盒（胶体金免疫层析法）
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
Source Content Issued by:	National Medical Products Adminstration
Issued on:	2020-06-30
Implemented on:	2022-6-1
Status:	valid
Target Language:	English
File Format:	PDF
Word Count:	5500 words
Translation Price(USD):	165.0
Delivery:	via email in 1~3 business day

本标准规定了口腔黏膜渗出液（Oral Mucosal Transudate，OMT）人类免疫缺陷病毒抗体检测试剂盒（胶体金免疫层析法）的要求、试验方法、标签和使用说明书、包装、运输和贮存。本标准适用于以胶体金免疫层析法为原理，对人口腔黏膜渗出液中的人类免疫缺陷病毒1型和2型（HIV-1/2）抗体进行定性检测的人类免疫缺陷病毒抗体检测试剂盒。