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Cystatin C Determination Reagent Kit (Latex-Enhanced Immune Transmission Turbidimetric Method) - NMPA Registration 鄂械注准20242405255

Access comprehensive regulatory information for Cystatin C Determination Reagent Kit (Latex-Enhanced Immune Transmission Turbidimetric 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 鄂械注准20242405255 and owned by Wuhan Changli BIOTECH Co., Ltd.. The device was approved on November 11, 2024.

This page provides complete registration details including registrant information, province location (Hubei), 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
鄂械注准20242405255
Cystatin C Determination Reagent Kit (Latex-Enhanced Immune Transmission Turbidimetric Method)
胱抑素C测定试剂盒（胶乳增强免疫透射比浊法）
NMPA Registration Number: 鄂械注准20242405255
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Pricing
Intended Use
English

用于定量检测人血清或血浆中胱抑素C的含量,主要作为反映肾小球滤过率的指标之一.

中文

用于定量检测人血清或血浆中胱抑素C的含量，主要作为反映肾小球滤过率的指标之一。

Device Classification
Device Class
Class II
Model Specifications
试剂1:1×20 mL 试剂2:1×5 mL、 试剂1:2×30 mL 试剂2:1×15 mL、试剂1:1×60 mL 试剂2:1×15 mL、试剂1:1×80 mL 试剂2:1×20 mL、试剂1:2×40 mL 试剂2:2×10 mL、试剂1:2×40 mL 试剂2:1×20 mL、试剂1:4×30 mL 试剂2:2×15 mL、试剂1:3×40 mL 试剂2:2×15 mL、试剂1:2×60 mL 试剂2:2×15 mL、试剂1:4×40 mL 试剂2:2×20 mL、试剂1:4×40 mL 试剂2:1×40 mL、试剂1:2×80 mL 试剂2:2×20 mL、试剂1:2×80 mL 试剂2:1×40 mL、试剂1:2×60 mL 试剂2:1×30 mL、试剂1:1×70 mL 试剂2:1×22 mL、试剂1:2×70 mL 试剂2:2×22 mL、496测试/盒(日立LST生化分析仪专用)、2×496测试/盒(日立LST生化分析仪专用).
试剂1：1×20 mL 试剂2：1×5 mL、 试剂1：2×30 mL 试剂2：1×15 mL、试剂1：1×60 mL 试剂2：1×15 mL、试剂1：1×80 mL 试剂2：1×20 mL、试剂1：2×40 mL 试剂2：2×10 mL、试剂1：2×40 mL 试剂2：1×20 mL、试剂1：4×30 mL 试剂2：2×15 mL、试剂1：3×40 mL 试剂2：2×15 mL、试剂1：2×60 mL 试剂2：2×15 mL、试剂1：4×40 mL 试剂2：2×20 mL、试剂1：4×40 mL 试剂2：1×40 mL、试剂1：2×80 mL 试剂2：2×20 mL、试剂1：2×80 mL 试剂2：1×40 mL、试剂1：2×60 mL 试剂2：1×30 mL、试剂1：1×70 mL 试剂2：1×22 mL、试剂1：2×70 mL 试剂2：2×22 mL、496测试/盒（日立LST生化分析仪专用）、2×496测试/盒（日立LST生化分析仪专用）。
Approval Department
Hubei Provincial Drug Administration
湖北省药品监督管理局
Registration Information
Registration Number
鄂械注准20242405255
Approval Date
November 11, 2024
Expiry Date
November 10, 2029
Registrant
Name
Wuhan Changli BIOTECH Co., Ltd.
武汉市长立生物技术有限责任公司
Province/Region
Hubei
湖北
Address
Room 01, 3rd floor, 4th floor, No. 388, Gaoxin 2nd Road, Wuhan Optics Valley International Biomedical Enterprise Accelerator, Phase 1.1, Phase 10, East Lake New Technology Development Zone, Wuhan
武汉市东湖新技术开发区高新二路388号武汉光谷国际生物医药企业加速器1.1期10栋3层01室、4层01室
Production Facility
Production Address
武汉市东湖新技术开发区高新二路388号武汉光谷国际生物医药企业加速器1.1期10栋一、三、四层
Structure and Composition
English

试剂1:甘氨酸缓冲液,Proclin300.试剂2:甘氨酸缓冲液,Proclin300,抗人CysC抗体胶乳颗粒.(具体内容详见说明书)

中文

试剂1：甘氨酸缓冲液，Proclin300。试剂2：甘氨酸缓冲液，Proclin300，抗人CysC抗体胶乳颗粒。（具体内容详见说明书）

Storage Conditions and Expiration
English

The validity period of the reagent in a sealed environment at 2 °C ~ 8 °C is 12 months.

中文

试剂在2℃～8℃避光环境密封保存中的有效期为12个月。

Additional Information
Appendix
产品技术要求、说明书