Alpha-2 Macroglobulin Assay Kit (Latex Enhanced Immune Turbidimetric Method) - NMPA Registration 皖械注准20242400161
Access comprehensive regulatory information for Alpha-2 Macroglobulin Assay Kit (Latex Enhanced Immune Turbidimetric 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 皖械注准20242400161 and owned by Anhui Iprocom Biotechnology Co., Ltd.. The device was approved on October 04, 2024.
This page provides complete registration details including registrant information, province location (Anhui), 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.
This product is used for in vitro quantitative determination of α2 macroglobulin content in human urine samples.
该产品用于体外定量测定人尿液样本中α2巨球蛋白的含量。
组成 主要成分 浓度 R1 3-吗啉-2-羟基丙磺酸 聚乙二醇-6000 50mmol/L 5g/L R2 Tris 缓冲液 胶乳包被α2 巨球蛋白抗体 牛血清白蛋白 50mmol/L 适量 10g/L 校准品 (选配) 3-吗啉-2-羟基丙磺酸 防腐剂 α2 巨球蛋白抗原 目标浓度:水平 1~水平 6 为 0.0mg/L、7.5mg/L、15.0mg/L、 30.0mg/L、60.0mg/L、120.0mg/L 质控品 水平一、 二(选 配) 3-吗啉-2-羟基丙磺酸 防腐剂 α2 巨球蛋白抗原 水平 1 目标浓度:4.0mg/L 水平 2 目标浓度:18.0mg/L
组成 主要成分 浓度 R1 3-吗啉-2-羟基丙磺酸 聚乙二醇-6000 50mmol/L 5g/L R2 Tris 缓冲液 胶乳包被α2 巨球蛋白抗体 牛血清白蛋白 50mmol/L 适量 10g/L 校准品 （选配） 3-吗啉-2-羟基丙磺酸 防腐剂 α2 巨球蛋白抗原 目标浓度：水平 1~水平 6 为 0.0mg/L、7.5mg/L、15.0mg/L、 30.0mg/L、60.0mg/L、120.0mg/L 质控品 水平一、 二（选 配） 3-吗啉-2-羟基丙磺酸 防腐剂 α2 巨球蛋白抗原 水平 1 目标浓度：4.0mg/L 水平 2 目标浓度：18.0mg/L
1. Unopened reagents, calibrators, and quality controls should be stored at 2°C~8°C in the dark, with an expiration date of 12 month, it is forbidden to freeze; 2. After opening the bottle, the reagent should be stored at 2°C~8°C in the dark, and the validity period is 28 days; 3. After opening the bottle, the calibrator should be stored in the dark at 2°C~ 8°C, pay attention to volatilization, and be valid for 2 days; 4. After opening the bottle, the quality control should be stored at 2°C~ 8°C in the dark, pay attention to volatilization, and be valid for 7 days.
1.未开封的试剂、校准品、质控品在 2℃~ 8℃避光保存，有效期 12 个 月，禁止冷冻； 2.开瓶后试剂在 2℃~ 8℃避光保存，有效期 28 天； 3.开瓶后的校准品 2℃~ 8℃避光保存，注意挥发，有效期 2 天； 4.开瓶后的质控品 2℃~ 8℃避光保存，注意挥发，有效期 7 天。