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China NMPA legacy archive 粤械注准20232400521

Erythrocyte Fragility Test Reagent Kit (Scattered Ratio Turbidity Method)

红细胞渗透脆性(EFT)测定试剂盒(散射比浊法)
Shenzhen Lifotronic Technology Co., Ltd.Class IINMPAApproved March 28, 2023
Static archiveNMPA · legacy registration snapshot
Device classification
Device class
Class II
Model specifications
1×5L/盒、1×2.5L/盒
Approval department
Guangdong Provincial Drug Administration
广东省药品监督管理局
Registration information
Registration number
粤械注准20232400521
Approval date
March 28, 2023
Expiry date
March 27, 2028
Registrant
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 facility
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
Intended use
English

The osmotic fragility of red blood cells is measured by measuring the tolerance of red blood cells to hypotonic sodium chloride solutions. Clinically, it is mainly used for the auxiliary diagnosis of reduced osmotic fragility of red blood cells.

中文

通过测定红细胞对低渗氯化钠溶液的耐受能力,检测红细胞渗透脆性。临床上主要用于红细胞渗透脆性降低的辅助诊断。

Structure and composition
English

It is composed of reaction solution and RFID card. Reaction solution: sodium chloride; RFID card: contains reagent batch number, test quantity information.

中文

由反应液、RFID卡组成。 反应液:氯化钠; RFID卡:内含试剂批号、测试数量信息。

Storage conditions and expiration
English

1. The reagent should be stored under sealed conditions at 2~30 °C, and the validity period is 12 months. 2. The opened reagent can be stored for 3 months under sealed storage conditions at 2~30 °C. 3. Avoid freezing.

中文

1、试剂应2~30℃密封条件下储存,有效期为12个月。 2、已开封的试剂,可在2~30℃密封储存条件下保存3个月。 3、避免冷冻。

Additional information
Appendix
产品技术要求、说明书
About this record

This static archive preserves historical registration fields and translations for Erythrocyte Fragility Test Reagent Kit (Scattered Ratio Turbidity Method), registration 粤械注准20232400521. It does not establish current authorization or complete current product details.

The default China search uses the separately verified domestic-registration listing, checked daily. Its published listing fields and scope differ from this older snapshot.