Human Irregular Antibody Screening Red Blood Cell Kit - NMPA Registration 国械注准20243401431
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.
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。