Blood lipid class composite quality control product - NMPA Registration 鲁械注准20222401338
Access comprehensive regulatory information for Blood lipid class 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20222401338 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.
Total cholesterol detection kit (CHOD-PAP method), total cholesterol detection kit (oxidase method), triglyceride detection kit (GPO-PAP method), triglyceride detection kit (oxidase method), high-density lipoprotein cholesterol detection kit (direct method - selective inhibition method), low-density lipoprotein cholesterol detection kit (direct method - surfactant clearance method), apolipoprotein A1 detection kit (immunotransmission turbidimetric method), The Apolipoprotein B Detection Kit (immunotransmission turbidimetry) is used in conjunction with the quality control of the analysis process of the above 8 items.
与本公司生产的总胆固醇检测试剂盒（CHOD-PAP法）、总胆固醇检测试剂盒（氧化酶法）、甘油三酯检测试剂盒（GPO-PAP法）、甘油三酯检测试剂盒（氧化酶法）、高密度脂蛋白胆固醇检测试剂盒（直接法-选择抑制法）、低密度脂蛋白胆固醇检测试剂盒（直接法-表面活性剂清除法）、载脂蛋白A1检测试剂盒（免疫透射比浊法）、载脂蛋白B检测试剂盒（免疫透射比浊法）配套使用，用于以上8个项目分析过程的质量控制。
Main components: bovine serum as matrix, serum contains a certain concentration of high-density lipoprotein cholesterol, low-density lipoprotein cholesterol, apolipoprotein A1, apolipoprotein B, total cholesterol, triglycerides, the concentration of the above components has batch specificity, the specific target range is shown in the attached table. The preservative Germal-115 (1ml/L), the lyophilized protective agent dimethyl sulfoxide (300mg/L) and the stabilizer PEG-6000 (200mg/L) are 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高密度脂蛋白胆固醇、低密度脂蛋白胆固醇、载脂蛋白A1、载脂蛋白B、总胆固醇、甘油三酯，以上成分浓度具有批特异性，具体靶值范围见附表。产品中添加防腐剂Germal-115(1ml/L)、冻干保护剂二甲基亚砜(300mg/L)和稳定剂PEG-6000（200mg/L）。
1. Unopened blood lipid composite quality control products are stored in the dark at 2~8 °C, and the validity period is 24 months. 2. After reconstitution, the blood lipid composite quality control is stored at room temperature (15~25 °C), and the validity period is 8 hours; 2~8°C storage, valid for 3 days; Store frozen at -20°C and valid for one month (Note: Please avoid repeated freeze-thaw). 3. The production date and expiration date are shown in the packaging label.
1.未开封的血脂类复合质控品在2~8℃避光保存，有效期为24个月。 2.复溶后血脂类复合质控品常温（15~25℃）保存，有效期为8小时；2~8℃保存，有效期3天；-20℃冰冻保存，有效期为一个月（注意：请避免反复冻融）。 3.生产日期及失效日期见包装标签。