Lipid Calibration Product
- Device class
- Class II
- Model specifications
- 1;1mL;3;1mL;1;2mL;3;2mL.1;1mL；3;1mL；1;2mL；3;2mL。
- Approval department
- Beijing Municipal Drug Administration北京市药品监督管理局
- Registration number
- 京械注准20242400666
- Approval date
- November 12, 2024
- Expiry date
- November 11, 2029
- Name
- Beijing Strong Biotechnologies,Inc.北京九强生物技术股份有限公司
- Province/Region
- Beijing北京
- Address
- 5th floor, Kuanyi Building, No. 15 Huayuan East Road, Haidian District, Beijing北京市海淀区花园东路15号旷怡大厦5层
- Production address
- 北京市怀柔区雁栖经济开发区雁栖北二街15号
Used in conjunction with our kit for calibration of clinical testing systems for triglyceride (TG), total cholesterol (CHO), high-density lipoprotein cholesterol (HDL-C), and low-density lipoprotein cholesterol (LDL-C) programs.
与本公司的试剂盒配套使用，用于甘油三酯（TG）、总胆固醇(CHO)、高密度脂蛋白胆固醇(HDL-C)、低密度脂蛋白胆固醇(LDL-C)项目临床检测系统的校准。
本校准品为人血清基质,单水平,冻干粉,血清基质百分比大于70%.具体内容见下表:注:校准品靶值批特异,详见校准品靶值单.
本校准品为人血清基质，单水平，冻干粉，血清基质百分比大于70%。具体内容见下表：注：校准品靶值批特异，详见校准品靶值单。
2℃ ~8℃密封避光保存,有效期18个月.
2℃ ~8℃密封避光保存，有效期18个月。
Access comprehensive regulatory information for Lipid Calibration 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20242400666 and owned by Beijing Strong Biotechnologies,Inc.. The device was approved on November 12, 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.