ABO Forward and Reverse Typing and RhD Blood Type Test Card (Microcolumn Gel Method) - NMPA Registration 国械注准20243400889
Access comprehensive regulatory information for ABO Forward and Reverse Typing and RhD Blood Type Test Card (Microcolumn Gel Method) in the China medical device market through Pure Global AI's free database. This Class III medical device is registered under NMPA registration number 国械注准20243400889 and owned by Aikang Diagnostics Co., Ltd.. The device was approved on May 09, 2024.
This page provides complete registration details including registrant information, province location (Guangdong), intended use, and regulatory compliance data from the official China NMPA medical device database. Pure Global AI offers free access to China's complete medical device registry, helping global MedTech companies navigate NMPA regulations efficiently.
本产品用于进行人ABO血型的正反定型检测及RhD血型抗原的检测，不用于血源筛查，仅用于临床检验。
检测卡由12个并排的充填等量葡聚糖凝胶的凝胶微柱构成，主要分为包被抗体的抗原柱为：含有抗A单克隆抗体（鼠源IgM，BIRMA-1），含有抗B单克隆抗体（鼠源IgM，LB-2），抗D单克隆抗体（人源IgM，RUM-1）；填充中性凝胶的反定型柱：Ac柱、Bc柱以及Ctl柱。
2~25 °C protected from light and erect, valid for 12 months.
2～25℃避光竖立保存，有效期为12个月。