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China NMPA legacy archive 京械注准20242400666

Lipid Calibration Product

脂类多项校准品
Beijing Strong Biotechnologies,Inc.Class IINMPAApproved November 12, 2024
Static archiveNMPA · legacy registration snapshot
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
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。

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。

About this record

This static archive preserves historical registration fields and translations for Lipid Calibration Product, registration 京械注准20242400666. It does not establish current authorization or complete current product details.

The default China search uses the separately verified domestic-registration listing, checked daily. Its published listing fields and scope differ from this older snapshot.