β2-microglobulin quality control product
- Device class
- Class II
- Model specifications
- 型号A(适用于血清、血浆)：低值：0.5mL×1 高值：0.5mL×1； 低值：1mL×1 高值：1mL×1。 型号B（适用于尿液）：低值：0.5mL×1 高值：0.5mL×1； 低值：1mL×1 高值：1mL×1。
- Approval department
- Jilin Provincial Drug Administration吉林省药品监督管理局
- Registration number
- 吉械注准20252400038
- Approval date
- January 14, 2025
- Expiry date
- January 13, 2030
- Name
- Dirui Industrial Co., Ltd.迪瑞医疗科技股份有限公司
- Province/Region
- Jilin吉林
- Address
- No. 95, Yunhe Street, Changchun High-tech Industrial Development Zone长春市高新技术产业开发区云河街95号
- Production address
- 长春市高新技术产业开发区云河街95号
本产品与本公司β2-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定量测定人血清、血浆、尿液样本β2-微球蛋白项目的质量控制。
型号A（适用于血清、血浆）： β2-微球蛋白（低值：1.5mg/L～5.4mg/L，高值：5.5mg/L～15mg/L）、三（羟甲基）氨基甲烷缓冲液≥5mmol/L、Proclin 300≥0.04%。 型号B（适用于尿液）： β2-微球蛋白（低值：0.3mg/L～1.4mg/L，高值：1.45mg/L～3.5mg/L）、三（羟甲基）氨基甲烷缓冲液≥5mmol/L、Proclin 300≥0.04%。
- Appendix
- 产品技术要求
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 吉械注准20252400038 and owned by Dirui Industrial Co., Ltd.. The device was approved on January 14, 2025.
This page provides complete registration details including registrant information, province location (Jilin), 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.