Immunofive Composite Calibration Solution - NMPA Registration 鲁械注准20232400830
Access comprehensive regulatory information for Immunofive Composite Calibration Solution 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20232400830 and owned by Biobase Biodustry (Shandong) Co., Ltd.. The device was approved on August 28, 2023.
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.
It is used in conjunction with the immunoglobulin IgA detection kit (immunoturbidimetric method), immunoglobulin IgG detection kit (immunoturbidimetric method), immunoglobulin IgM detection kit (immunoturbidimetric method), complement C3 detection kit (immunoturbidimetric method), and complement C4 detection kit (immunoturbidimetric method) produced by the company to establish the working curve of the included items and the calibration of the applicable instrument detection system.
与本公司生产的免疫球蛋白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）、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）配套使用，用于建立所含项目的工作曲线和适用仪器检测系统的校准。
Main components: Bovine serum as the matrix, add immunoglobulin crude antigen, serum contains a certain concentration of immunoglobulin A, immunoglobulin G, immunoglobulin M, complement C3, complement C4, the concentration of the above components has batch specificity. The traceability of the calibrators is shown in Schedule 1. In order to maintain the stability of the product, the preservative Germal-115 (1mL/L), the lyophilized protective agent dimethyl sulfoxide (300mg/L) and the stabilizer PEG-6000 (200mg/L) were added to the product.
主要组成成分： 牛血清为基质，添加免疫球蛋白粗抗原，血清中含有一定浓度的免疫球蛋白A、免疫球蛋白G、免疫球蛋白M、补体C3、补体C4，以上成分浓度具有批特异性。校准品的溯源性见附表1。为保持产品的稳定性，产品中添加了防腐剂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 immune five-item composite calibrators are stored in a dark environment of 2 °C ~ 8 °C without corrosive gas, and the validity period is 12 months. 2. After the first reconstitution of the immune five-item composite calibrator, it is sealed and protected from light at 2 °C ~ 8 °C and stored in the absence of corrosive gas and pollution, and the validity period is 3 days; the validity period is 8 hours when it is sealed and protected from light at room temperature (15 °C ~ 25 °C) without corrosive gas and pollution; the validity period is 30 days when it is sealed and protected from light at -20 °C without corrosive gas and pollution. Avoid repeated freeze-thaw.
1.未开封的免疫五项复合校准品在2℃~8℃、无腐蚀性气体的避光环境中贮存有效期为12个月。 2.免疫五项复合校准品首次复溶后2℃~8℃密封避光保存于无腐蚀性气体、无污染情况下有效期3天；常温（15℃~25℃）密封避光保存于无腐蚀性气体、无污染情况下有效期8小时；-20℃密封避光保存于无腐蚀性气体、无污染情况下有效期30天。避免反复冻融。