Cholesterol test strips (electrochemical) - NMPA Registration 湘械注准20242400804
Access comprehensive regulatory information for Cholesterol test strips (electrochemical) in the China medical device market through Pure Global AI's free database. This Class II medical device is registered under NMPA registration number 湘械注准20242400804 and owned by Fosun Diagnostic Technology (Changsha) Co., Ltd. The device was approved on September 02, 2024.
This page provides complete registration details including registrant information, province location (Hunan), 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.
It is used for in vitro quantitative detection of cholesterol concentration in human fresh fingertip peripheral whole blood and/or venous whole blood, and can be used for professional testing and non-professional self-testing.
用于体外定量检测人体新鲜指尖末梢全血和/或静脉全血中的胆固醇浓度, 可用于专业人员检测和非专业人员自测。
The test strip is composed of a carbon electrode bare plate, a reagent, a separator, and a protective coverslip, and each test strip contains cholesterol oxidase≥ 0.60U, electronic enzyme mediator≥ 36 μg, and non-reactive substance > 65 μg. The test strip box contains a special code card. The cholesterol quality control solution is composed of purified water, high-concentration cholesterol concentrate, thickener, inorganic salts, stabilizers, and bacteriostatic agents.
试纸条由碳电极裸板、试剂、隔片、保护盖片组成,每片试纸条含胆固醇氧化酶≥0.60U、电子酶介体≥36μg、非反应物质>65μg。试纸条盒内含配套专用Code卡。胆固醇质控液是由纯化水、高浓度胆固醇浓缩液、增稠剂、无机盐类、稳定剂、抑菌剂组成。
1. The validity period of the unopened test strip at 4~30°C and humidity ≤80%RH is 10 months; Protect from light and do not freeze. 2. After the barrel test strip is opened, it is stored at 4~30°C and humidity ≤80%RH, and the validity period is 3 months. 3. Quality control solution: 4~30°C, humidity ≤ 80%RH, the validity period of unopened products is 6 months; After opening, the storage period is 3 months at 4~30°C and humidity ≤80%RH. 4. The production date and expiration date are shown on the box label.
1.在4～30℃、湿度≤80％RH下未开瓶试纸条的有效期为10个月；避光、禁止冷冻。2.桶装试纸条开盖后4～30℃、湿度≤80％RH下储存有效期为3个月。3.质控液：4～30℃、湿度≤80％RH下，未开瓶产品的有效期为6个月；开瓶后4～30℃、湿度≤80％RH下储存有效期为3个月。4.生产日期、失效日期见盒标签。