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总铁结合力(TIBC)校准品 - NMPA Registration 京械注准20242400629

Access comprehensive regulatory information for 总铁结合力(TIBC)校准品 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20242400629 and owned by Beijing Leadman Biochemistry Co., Ltd.. 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.

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Class II
京械注准20242400629
总铁结合力(TIBC)校准品
总铁结合力(TIBC)校准品
NMPA Registration Number: 京械注准20242400629
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Intended Use
English

与本公司生产的总铁结合力(TIBC)测定试剂盒(Ferene法)配套使用,用于建立校准曲线.

中文

与本公司生产的总铁结合力(TIBC)测定试剂盒(Ferene法)配套使用,用于建立校准曲线。

Device Classification
Device Class
Class II
Model Specifications
Fe校准品:1;1mL.UIBC校准品:1;1mL.
Fe校准品:1;1mL。UIBC校准品:1;1mL。
Approval Department
Beijing Municipal Drug Administration
北京市药品监督管理局
Registration Information
Registration Number
京械注准20242400629
Approval Date
November 08, 2024
Expiry Date
November 07, 2029
Registrant
Name
Beijing Leadman Biochemistry Co., Ltd.
北京利德曼生化股份有限公司
Province/Region
Beijing
北京
Address
No. 5 Xinghai Road, Beijing Economic and Technological Development Zone, Beijing
北京市北京经济技术开发区兴海路5号
Production Facility
Production Address
北京市北京经济技术开发区兴海路5号1幢2层、6层、B1层、2幢
Structure and Composition
English

Fe校准品:单水平的液态校准品,在盐酸缓冲液(pH=1.70plusmn;0.20)中添加Fe离子.靶值浓度范围:80.0mu;mol/L~120.0mu;mol/L.UIBC校准品:单水平的液态校准品.在3-吗啉丙磺酸缓冲液(pH=7.80plusmn;0.20)中添加脱铁转铁蛋白、牛血清白蛋白、叠氮钠.靶值浓度范围:50.0mu;mol/L~70.0mu;mol/L.校准品浓度具有批特异性,具体数值见标签.

中文

Fe校准品:单水平的液态校准品,在盐酸缓冲液(pH=1.70plusmn;0.20)中添加Fe离子。靶值浓度范围:80.0mu;mol/L~120.0mu;mol/L。UIBC校准品:单水平的液态校准品。在3-吗啉丙磺酸缓冲液(pH=7.80plusmn;0.20)中添加脱铁转铁蛋白、牛血清白蛋白、叠氮钠。靶值浓度范围:50.0mu;mol/L~70.0mu;mol/L。校准品浓度具有批特异性,具体数值见标签。

Storage Conditions and Expiration
English

Store at 2°C~8°C, valid for 6 months.

中文

2℃~8℃保存,有效期6个月。

Additional Information
Changes
产品过期日期变更为:2℃~8℃保存,有效期6个月。。
Appendix
产品技术要求、说明书