β2-microglobulin quality control product
- Device class
- Class II
- Model specifications
- 水平1:1mL;1,水平2:1mL;1.水平1：1mL;1，水平2：1mL;1。
- Approval department
- Beijing Municipal Drug Administration北京市药品监督管理局
- Registration number
- 京械注准20242400623
- 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尿液样本beta;2-微球蛋白项目的室内质量控制.
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尿液样本beta;2-微球蛋白项目的室内质量控制。
磷酸盐缓冲液,10mmol/L;两个水平,目标浓度范围为水平1:0.14mg/L～0.32mg/L;水平2:1.12mg/L～2.08mg/L.每批定值,值有批特异性,详见值单.
磷酸盐缓冲液，10mmol/L；两个水平，目标浓度范围为水平1：0.14mg/L～0.32mg/L；水平2：1.12mg/L～2.08mg/L。每批定值，值有批特异性，详见值单。
2℃～8℃避光贮存,有效期18个月.
2℃～8℃避光贮存，有效期18个月。
- Changes
- 产品过期日期变更为：2℃～8℃避光贮存，有效期18个月。。
- Appendix
- 产品技术要求、说明书
Access comprehensive regulatory information for β2-microglobulin quality control product 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20242400623 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.