Red blood cell osmotic fragility (EFT) quality control product
- Device class
- Class II
- Model specifications
- 2×0.5mL/box, 2×1.0mL/box2×0.5mL/盒、2×1.0mL/盒
- Approval department
- Guangdong Provincial Drug Administration广东省药品监督管理局
- Registration number
- 粤械注准20232400522
- Approval date
- March 28, 2023
- Expiry date
- March 27, 2028
- Name
- Shenzhen Lifotronic Technology Co., Ltd.深圳普门科技股份有限公司
- Province/Region
- Guangdong广东
- Address
- 1st floor, Jindi Tianyue Bay, No. 8 Qizhi East Road, Guancheng Community, Guanhu Street, Longhua District, Shenzhen (intersection of Meiguan Expressway and Huanguan South Road).深圳市龙华区观湖街道观城社区求知东路8号金地天悦湾（梅关高速与环观南路交汇处）1层
- Production address
- 广东省东莞市松山湖园区彰化路2号1号厂房4-9楼、11楼
This product is used with the automatic erythrocyte osmotic fragility analyzer produced by Shenzhen Pumen Technology Co., Ltd., which is mainly used for the quality control of the erythrocyte osmotic fragility analysis system.
本产品与深圳普门科技股份有限公司生产的全自动红细胞渗透脆性分析仪配套使用，主要用于红细胞渗透脆性分析系统的质量控制。
Consists of erythrocyte osmotic fragility (EFT) control level I and erythrocyte osmotic fragility (EFT) control level II. Red blood cell osmotic fragility (EFT) control level I: animal red blood cells, preservative (gentamicin), phosphate buffer. Erythrocyte osmotic fragility (EFT) control level II: animal erythrocytes, preservative (gentamicin), phosphate buffer.
由红细胞渗透脆性(EFT)质控品水平I和红细胞渗透脆性(EFT)质控品水平II组成。 红细胞渗透脆性(EFT)质控品水平I：动物红细胞、防腐剂（庆大霉素）、磷酸盐缓冲液。 红细胞渗透脆性(EFT)质控品水平II：动物红细胞、防腐剂（庆大霉素）、磷酸盐缓冲液。
When the bottle is not opened, the quality control is stored at 2~8 °C, and the validity period is 12 months; After opening, it can be stored for 1 month at 2~8 °C; It can be stably stored for 12 hours at 16~30 °C.
未开瓶时，质控品在2~8℃储存条件下，有效期为 12个月；开瓶后，在2~8℃下可保存1个月；在16~30℃下可稳定保存12个小时。
- Appendix
- 产品技术要求、说明书
Access comprehensive regulatory information for Red blood cell osmotic fragility (EFT) quality control product in the China medical device market through Pure Global AI's free database. This Class II medical device is registered under NMPA registration number 粤械注准20232400522 and owned by Shenzhen Lifotronic Technology Co., Ltd.. The device was approved on March 28, 2023.
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.