ABO Forward and Reverse Typing and RhD Blood Type Test Card (Microcolumn Gel Method)
- Device class
- Class III
- Model specifications
- 12孔/卡，5×8卡/盒
- Approval department
- State Drug Administration国家药品监督管理局
- Registration number
- 国械注准20243400889
- Approval date
- May 09, 2024
- Expiry date
- May 08, 2029
- Name
- Aikang Diagnostics Co., Ltd.深圳市爱康试剂有限公司
- Province/Region
- Guangdong广东
- Address
- 401-1201, Building 1, iKang Biotechnology, No. 66 Juqing Road, Jinsha Community, Kengzi Street, Pingshan District, Shenzhen深圳市坪山区坑梓街道金沙社区聚青路66号爱康生物1号楼401-1201
- Production address
- 深圳市坪山区坑梓街道金沙社区聚青路66号爱康生物1号楼整栋（2楼、3楼除外）
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。
- Changes
- 2024-05-14 变更注册证载明的生产地址由深圳市龙华区观澜街道新澜社区观光路1303号鸿信工业园3号厂房501；1号厂房501;变更为：深圳市坪山区坑梓街道金沙社区聚青路66号爱康生物1号楼整栋（2楼、3楼除外）
- Appendix
- 产品技术要求、说明书
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.