Special protein composite quality control product - NMPA Registration 鲁械注准20222401339
Access comprehensive regulatory information for Special protein composite 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 鲁械注准20222401339 and owned by Biobase Biodustry (Shandong) Co., Ltd.. The device was approved on November 24, 2022.
This page provides complete registration details including registrant information, province location (Shandong), 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.
Anti-streptococcal O detection kit (immunoturbidimetric method), C-reactive protein detection kit (immunoturbidimetric method), C-reactive protein detection kit (latex immunoturbidimetric method), complement C3 detection kit (immunoturbidimetric method), complement C4 detection kit (immunoturbidimetric method), immunoglobulin IgA detection kit (immunoturbidimetric method), immunoglobulin IgG detection kit (immunoturbidimetric method), immunoglobulin IgM detection kit (immunoturbidimetric method), The prealbumin detection kit (immunoturbidimetric method), rheumatoid factor detection kit (immunotransmission turbidimetric method), and transferrin detection kit (immunoturbidimetric method) are used together for the quality control of the analysis process of the above 11 items.
与本公司生产的抗链球菌O检测试剂盒（免疫比浊法），C反应蛋白检测试剂盒（免疫比浊法），C反应蛋白检测试剂盒（胶乳免疫比浊法），补体C3检测试剂盒（免疫比浊法），补体C4检测试剂盒（免疫比浊法），免疫球蛋白IgA检测试剂盒（免疫比浊法），免疫球蛋白IgG检测试剂盒（免疫比浊法），免疫球蛋白IgM检测试剂盒（免疫比浊法），前白蛋白检测试剂盒（免疫比浊法），类风湿因子检测试剂盒（免疫透射比浊法）, 转铁蛋白检测试剂盒（免疫比浊法）配套使用，用于以上11个项目分析过程的质量控制。
Main components: bovine serum as matrix, serum contains a certain concentration of anti-streptococcal O, C reactive protein, complement C3, complement C4, immunoglobulin IgA, immunoglobulin IgG, immunoglobulin IgM, prealbumin, rheumatoid factor, transferrin, the concentration of the above components has batch specificity, the specific target range is shown in the attached table. In order to maintain the stability of the product, disodium hydrogen phosphate dodecahydrate (20mg/L), potassium dihydrogen phosphate (30mg/L), sodium chloride (20mg/L), polyoxyethylene laureth (10mg/L), EDTA.2Na (20mg/L), sucrose (40mg/L), PC300 (1mL/L) preservative Germal-115 (20mg/L) and stabilizer PEG-6000 (30mg/L) were added to the product.
主要组成成分：牛血清为基质，血清中含有一定浓度的抗链球菌O，C反应蛋白，补体C3，补体C4，免疫球蛋白IgA，免疫球蛋白IgG，免疫球蛋白IgM，前白蛋白，类风湿因子，转铁蛋白，以上成分浓度具有批特异性，具体靶值范围见附表。为保持产品的稳定性，产品中添加了十二水合磷酸氢二钠（20mg/L）、磷酸二氢钾（30mg/L）、氯化钠（20mg/L）、聚氧乙烯月桂醚（10mg/L）、EDTA.2Na（20mg/L）、蔗糖（40mg/L）、PC300（1mL/L） 防腐剂Germal-115（20mg/L）和稳定剂PEG-6000（30mg/L）。
1. Unopened special protein complex quality control is stored in the dark at 2~8 °C, and the validity period is 18 months. 2. After the first opening, the special protein composite quality control is stored at 2~8 °C in the dark, and the validity period is 30 days. 3. Do not freeze. 4. The production date and expiration date are shown in the packaging label.
1.未开封的特种蛋白复合质控品在2~8℃避光保存，有效期为18个月。 2.首次开封后特种蛋白复合质控品2~8℃避光保存，有效期为30天。 3.不可冷冻。 4.生产日期及失效日期见包装标签。