Standard No.:	YY/T 1214-2019
English Name:	Human chorionic gonadotrophin detection kit
Chinese Name:	人绒毛膜促性腺激素测定试剂盒
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:	2019-07-24
Implemented on:	2020-8-1
Status:	valid
Superseding:	YY/T 1214-2013 Human chorionic gonadotrophin quantitative labelling immunoassay kit
Target Language:	English
File Format:	PDF
Word Count:	5500 words
Translation Price(USD):	165.0
Delivery:	via email in 1~3 business day

本标准规定了人绒毛膜促性腺激素测定试剂盒的分类、要求、试验方法、标签和使用说明书、包装、运输、贮存。本标准适用于以双抗体夹心法为原理定量测定人绒毛膜促性腺激素的试剂盒，包括以酶标记、（电）化学发光标记、（时间分辨）荧光标记等标记方法的免疫分析试剂盒。本标准不适用于用胶体金或其它方法标记的半定量测定人绒毛膜促性腺激素的试剂（如：试纸条等）；用125I等放射性同位素标记的各类人绒毛膜促性腺激素放射免疫或免疫放射试剂盒。本标准代替YY/T 1214-2013《人绒毛膜促性腺激素定量标记免疫分析试剂盒》。