β2-microglobulin calibration material
- Device class
- Class II
- Model specifications
- 1mL;5
- Approval department
- Beijing Municipal Drug Administration北京市药品监督管理局
- Registration number
- 京械注准20242400626
- Approval date
- November 08, 2024
- Expiry date
- November 07, 2029
- Name
- Biosino BIO-TECHNOLOGY and Science INC.中生北控生物科技股份有限公司
- Province/Region
- Beijing北京
- Address
- No. 27, Chaoqian Road, Science and Technology Park, Changping District, Beijing北京市昌平区科技园区超前路27号
- Production address
- 北京市昌平区科技园区超前路27号
与本公司beta;2-微球蛋白测定试剂盒(胶乳免疫比浊法)配套使用,用于临床检验实验室测定血清样本beta;2-微球蛋白项目定量检测的系统校准.
与本公司beta;2-微球蛋白测定试剂盒（胶乳免疫比浊法）配套使用，用于临床检验实验室测定血清样本beta;2-微球蛋白项目定量检测的系统校准。
磷酸盐缓冲液,10mmol/L;五个浓度,目标浓度分别为浓度2:1.5mg/L、浓度3:5.0mg/L、浓度4:10.0mg/L、浓度5:30.0mg/L、浓度6:50.0mg/L.每批定值,值有批特异性,详见值单.
磷酸盐缓冲液，10mmol/L；五个浓度，目标浓度分别为浓度2：1.5mg/L、浓度3：5.0mg/L、浓度4：10.0mg/L、浓度5：30.0mg/L、浓度6：50.0mg/L。每批定值，值有批特异性，详见值单。
2℃～8℃贮存,有效期18个月.
2℃～8℃贮存，有效期18个月。
- Changes
- 产品过期日期变更为：2℃～8℃贮存，有效期18个月。。
- Appendix
- 产品技术要求、说明书
Access comprehensive regulatory information for β2-microglobulin calibration material in the China medical device market through Pure Global AI's free database. This Class II medical device is registered under NMPA registration number 京械注准20242400626 and owned by Biosino BIO-TECHNOLOGY and Science INC.. The device was approved on November 08, 2024.
This page provides complete registration details including registrant information, province location (Beijing), 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.