Uric Acid Test Strip (Electrochemical Method) - NMPA Registration 湘械注准20242400806
Access comprehensive regulatory information for Uric Acid Test Strip (Electrochemical 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 湘械注准20242400806 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 monitoring of uric acid 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.
用于体外定量监测人体新鲜指尖末梢全血和/或静脉全血中的尿酸浓度, 可用于专业人员检测和非专业人员自测。
The test strip is composed of silver chloride paste, carbon pulp, hydrophilic film and PET substrate, and each test strip contains about 0.01mg of oxidizing electron mediator, about 0.15U of ascorbate oxidase, and about 0.001mg of other protective substances that do not participate in the reaction. The test strip box contains a special code card. Uric acid quality control solution is composed of purified water, uric acid, thickeners, inorganic salts, and bacteriostatic agents.
试纸条由氯化银浆、碳浆、亲水膜、PET基板组成,每片试纸条含氧化性电子介体约0.01mg,抗坏血酸氧化酶约0.15U,其它不参与反应的保护性物质约0.001mg。试纸条盒内含配套专用Code卡。尿酸质控液由纯化水、尿酸、增稠剂、无机盐类、抑菌剂组成。
1. Barreled test strips: under 4~30°C, humidity ≤80%RH, the validity period of unopened products is 8 months; After opening the lid, the storage period is 3 months at 4~30°C and humidity ≤ 80%RH; Protect from light and do not freeze. 2. Quality control solution: 4~30°C, humidity ≤ 80%RH, the validity period of unopened products is 10 months; After opening, the storage period is 3 months at 4~30°C and humidity ≤80%RH. 3. The production date and expiration date are shown on the box label.
1.桶装试纸条：在4～30℃、湿度≤80％RH下，未开瓶产品的有效期为8个月；开盖后4～30℃、湿度≤80％RH下储存有效期为3个月；避光、禁止冷冻。2.质控液：4～30℃、湿度≤80％RH下，未开瓶产品的有效期为10个月；开瓶后4～30℃、湿度≤80％RH下储存有效期为3个月。3.生产日期、失效日期见盒标签。