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Lipid Calibration Product - NMPA Registration 京械注准20242400666

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.

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NMPA Official Data
Class II
京械注准20242400666
Lipid Calibration Product
脂类多项校准品
NMPA Registration Number: 京械注准20242400666
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Intended Use
English

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.

中文

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。

Device Classification
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 Information
Registration Number
京械注准20242400666
Approval Date
November 12, 2024
Expiry Date
November 11, 2029
Registrant
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 Facility
Production Address
北京市怀柔区雁栖经济开发区雁栖北二街15号
Structure and Composition
English

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.

中文

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。

Storage Conditions and Expiration
English

2℃ ~8℃密封避光保存,有效期18个月.

中文

2℃ ~8℃密封避光保存,有效期18个月。