Immunoglobulin M (IgM) Test Kit (Scattered Turbidimetric Method)
- Device class
- Class II
- Model specifications
- 稀释缓冲液:15mL×1,抗体-胶乳溶液:5mL×1; 稀释缓冲液:25mL×1,抗体-胶乳溶液:9mL×1; 稀释缓冲液:25mL×2,抗体-胶乳溶液:9mL×2; 稀释缓冲液:25mL×2,抗体-胶乳溶液:17mL×1; 稀释缓冲液:30mL×1,抗体-胶乳溶液:10mL×1; 稀释缓冲液:30mL×2,抗体-胶乳溶液:20mL×1; 稀释缓冲液:60mL×1,抗体-胶乳溶液:20mL×1; 稀释缓冲液:60mL×2,抗体-胶乳溶液:20mL×2; 稀释缓冲液:750mL×1,抗体-胶乳溶液:250mL×1; 稀释缓冲液:3000mL×1,抗体-胶乳溶液:1000mL×1; 20T/盒;50T/盒;100T/盒;200T/盒;400T/盒;1000T/盒. 校准品(选配)(5水平):5×0.5mL、5×1mL.稀释缓冲液：15mL×1，抗体-胶乳溶液：5mL×1； 稀释缓冲液：25mL×1，抗体-胶乳溶液：9mL×1； 稀释缓冲液：25mL×2，抗体-胶乳溶液：9mL×2； 稀释缓冲液：25mL×2，抗体-胶乳溶液：17mL×1； 稀释缓冲液：30mL×1，抗体-胶乳溶液：10mL×1； 稀释缓冲液：30mL×2，抗体-胶乳溶液：20mL×1； 稀释缓冲液：60mL×1，抗体-胶乳溶液：20mL×1； 稀释缓冲液：60mL×2，抗体-胶乳溶液：20mL×2； 稀释缓冲液：750mL×1，抗体-胶乳溶液：250mL×1； 稀释缓冲液：3000mL×1，抗体-胶乳溶液：1000mL×1； 20T/盒；50T/盒；100T/盒；200T/盒；400T/盒；1000T/盒。 校准品（选配）（5水平）：5×0.5mL、5×1mL。
- Approval department
- Chongqing Municipal Drug Administration重庆市药品监督管理局
- Registration number
- 渝械注准20242400482
- Approval date
- December 11, 2024
- Expiry date
- December 10, 2029
- Name
- Chongqing Biostec Biological Technology Co., Ltd.重庆博士泰生物技术有限公司
- Province/Region
- Chongqing重庆
- Address
- 1st and 2nd floor, Building 2, No. 17, Camellia Road, Changshengqiao Town, Nan'an District, Chongqing重庆市南岸区长生桥镇茶花路17号2幢1、2楼
- Production address
- 重庆市南岸区茶花路17号2幢1楼、2楼、3楼2-1、2-2
用于体外定量检测人体样本(脑脊液)中免疫球蛋白M(IgM)的含量.临床上主要用于免疫功能的评价及免疫疾病的辅助诊断.
用于体外定量检测人体样本（脑脊液）中免疫球蛋白M（IgM）的含量。临床上主要用于免疫功能的评价及免疫疾病的辅助诊断。
由稀释缓冲液、抗体-胶乳溶液、校准品(选配)组成.(具体内容详见产品说明书)
由稀释缓冲液、抗体-胶乳溶液、校准品（选配）组成。(具体内容详见产品说明书)
本品在2～8℃密闭保存可稳定18个月.试剂开瓶后在2～8℃条件下保存并应在14天内使用,校准品开瓶后在2～8℃条件下可保存7天.
本品在2～8℃密闭保存可稳定18个月。试剂开瓶后在2～8℃条件下保存并应在14天内使用，校准品开瓶后在2～8℃条件下可保存7天。
Access comprehensive regulatory information for Immunoglobulin M (IgM) Test Kit (Scattered 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 渝械注准20242400482 and owned by Chongqing Biostec Biological Technology Co., Ltd.. The device was approved on December 11, 2024.
This page provides complete registration details including registrant information, province location (Chongqing), 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.