Erythrocyte Fragility Test Reagent Kit (Scattered Ratio Turbidity Method) - NMPA Registration 粤械注准20232400521
Access comprehensive regulatory information for Erythrocyte Fragility Test Reagent Kit (Scattered Ratio Turbidity Method) 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20232400521 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.
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.
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。
It is composed of reaction solution and RFID card. Reaction solution: sodium chloride; RFID card: contains reagent batch number, test quantity information.
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。
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.
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。