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Urine transferrin detection kit (latex immunoturbidimetric method) - NMPA Registration 川械注准20252400001

Access comprehensive regulatory information for Urine transferrin detection kit (latex immunoturbidimetric method) in the China medical device market through Pure Global AI's free database. This Class II medical device is registered under NMPA registration number 川械注准20252400001 and owned by Maccura Biotechnology Co., Ltd.. The device was approved on January 08, 2025.

This page provides complete registration details including registrant information, province location (Sichuan), 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
川械注准20252400001
Urine transferrin detection kit (latex immunoturbidimetric method)
尿转铁蛋白测定试剂盒(胶乳免疫比浊法)
NMPA Registration Number: 川械注准20252400001
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Pricing
Intended Use
English

本品用于体外定量测定人尿液样本中转铁蛋白的含量。

Device Classification
Device Class
Class II
Model Specifications
试剂1 30mL×1试剂2 15mL×1; 试剂1 60mL×2试剂2 30mL×2; 试剂1 50mL×4试剂2 25mL×4; 试剂1 30mL×4试剂2 15mL×4; 200测试×2/盒(迈克生化分析仪专用); 200测试×4/盒(迈克生化分析仪专用); 210测试×4/盒(迈克生化分析仪专用); 310测试×4/盒(迈克生化分析仪专用); 510测试×4/盒(迈克生化分析仪专用); 200测试×2/盒(日立LST生化分析仪专用); 200测试×4/盒(日立LST生化分析仪专用); 400测试×2/盒(日立LST生化分析仪专用); 400测试×4/盒(日立LST生化分析仪专用)。 校准品:校准品1~5 0.5mL×5。 质控品: 水平1 1.0mL×1;水平2 1.0mL×1; 水平1~2 1.0mL×2。
Approval Department
Sichuan Provincial Drug Administration
四川省药品监督管理局
Registration Information
Registration Number
川械注准20252400001
Approval Date
January 08, 2025
Expiry Date
January 07, 2030
Registrant
Name
Maccura Biotechnology Co., Ltd.
迈克生物股份有限公司
Province/Region
Sichuan
四川
Address
No. 16, Baichuan Road, Chengdu High-tech Zone
成都市高新区百川路16号
Production Facility
Production Address
成都市高新区百川路16号
Structure and Composition
English

试剂盒包含试剂1(R1):三羟甲基氨基甲烷(10~200)mmoL/L;试剂2(R2):兔抗人转铁蛋白多克隆抗体(50~200)mg/L、胶乳(10~100)ml/L;校准品:转铁蛋白;质控品:转铁蛋白。(具体内容详见产品说明书)

Storage Conditions and Expiration
English

本品于2℃~8℃密闭避光保存,严禁冷冻,有效期为18个月。

Additional Information
Appendix
产品技术要求、说明书