Human Irregular Antibody Screening Red Blood Cell Kit
- Device class
- Class III
- Model specifications
- 1 vial each of I., II., III. red blood cells, 5 mL/vial (3% or 0.8% concentration)Ⅰ、Ⅱ、Ⅲ红细胞各1瓶，5mL/瓶（3%或0.8%浓度）
- Approval department
- State Drug Administration国家药品监督管理局
- Registration number
- 国械注准20243401431
- Approval date
- August 05, 2024
- Expiry date
- August 04, 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
This kit is used for in vitro qualitative detection of irregular antibodies in human plasma, and is only used for clinical testing, not for blood screening.
本试剂盒用于体外定性检测人血浆中的不规则抗体，仅用于临床检验，不用于血源筛查。
本试剂盒含有三个的单人份的O型红细胞(含有D、C、c、E、e、Jka、Jkb、M、N、S、s、Fya、Fyb、Lea、Leb、Dia、k、P1抗原)、细胞保存液(含有氯化钠、葡萄糖等)组成. (具体内容详见说明书)
本试剂盒含有三个的单人份的O型红细胞（含有D、C、c、E、e、Jka、Jkb、M、N、S、s、Fya、Fyb、Lea、Leb、Dia、k、P1抗原）、细胞保存液（含有氯化钠、葡萄糖等）组成。(具体内容详见说明书)
Store at 2~8°C and have an expiration date of 3 months.
2～8℃储存，有效期为3个月。
- Appendix
- 产品技术要求、说明书
Access comprehensive regulatory information for Human Irregular Antibody Screening Red Blood Cell Kit 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20243401431 and owned by Aikang Diagnostics Co., Ltd.. The device was approved on August 05, 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.