皖械注准20242400161

Alpha-2 Macroglobulin Assay Kit (Latex Enhanced Immune Turbidimetric Method)

α2巨球蛋白测定试剂盒(胶乳增强免疫比浊法)
Anhui Iprocom Biotechnology Co., Ltd.·Class II·NMPA·Approved October 04, 2024
Device classification
Device class
Class II
Model specifications
1、R1:1×30mL,R2:1×6mL 2、R1:1×40mL,R2:1×8mL 3、R1:1×50mL,R2:1×10mL 4、R1:2×40mL,R2:2×8mL 5、R1:2×25mL,R2:1×10mL 6、R1:2×50mL,R2:1×20mL 7、R1:2×50mL,R2:2×10mL 8、12×60 测试9、50测试 10、100测试,11、200测试 12、400测试,13、600测试 14、800测试 校准品规格:6×0.5mL、6×1mL、6×2mL、6×5mL 质控品规格:2×0.5mL、2×1mL、2×2mL、2×5mL
1、R1:1×30mL,R2:1×6mL 2、R1:1×40mL,R2:1×8mL 3、R1:1×50mL,R2:1×10mL 4、R1:2×40mL,R2:2×8mL 5、R1:2×25mL,R2:1×10mL 6、R1:2×50mL,R2:1×20mL 7、R1:2×50mL,R2:2×10mL 8、12×60 测试9、50测试 10、100测试,11、200测试 12、400测试,13、600测试 14、800测试 校准品规格:6×0.5mL、6×1mL、6×2mL、6×5mL 质控品规格:2×0.5mL、2×1mL、2×2mL、2×5mL
Approval department
Anhui Provincial Drug Administration
安徽省药品监督管理局
Registration information
Registration number
皖械注准20242400161
Approval date
October 04, 2024
Expiry date
October 03, 2029
Registrant
Name
Anhui Iprocom Biotechnology Co., Ltd.
安徽伊普诺康生物技术股份有限公司
Province/Region
Anhui
安徽
Address
No. 659, Lanzhou Road, Baohe District, Hefei
合肥市包河区兰州路659号
Production facility
Production address
合肥市包河区兰州路659号
Intended use
English

This product is used for in vitro quantitative determination of α2 macroglobulin content in human urine samples.

中文

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。

Structure and composition
English

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

中文

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

Storage conditions and expiration
English

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.

中文

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。

Additional information
Appendix
产品技术要求、说明书
About this record

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.