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Immunoglobulin A Test Kit (Immunotransmission Turbidimetry Method) - NMPA Registration 鄂械注准20242405253

Access comprehensive regulatory information for Immunoglobulin A Test Kit (Immunotransmission Turbidimetry 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20242405253 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20242405253
Immunoglobulin A Test Kit (Immunotransmission Turbidimetry Method)
免疫球蛋白A测定试剂盒（免疫透射比浊法）
NMPA Registration Number: 鄂械注准20242405253
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Intended Use
English

It is used to quantitatively detect the content of immunoglobulin A in human serum and plasma.

中文

用于定量检测人血清、血浆中免疫球蛋白A的含量。

Device Classification
Device Class
Class II
Model Specifications
试剂1:15 mL×1 试剂2:5 mL×1、 试剂1:30 mL×2 试剂2:20 mL×1、试剂1:60 mL×1 试剂2:20 mL×1、试剂1:30 mL×3 试剂2:15 mL×2、试剂1:45 mL×2 试剂2:15 mL×2、试剂1:45 mL×2 试剂2:30 mL×1、试剂1:90 mL×1 试剂2:30 mL×1、试剂1:40 mL×3 试剂2:40 mL×1、试剂1:60 mL×2 试剂2:20 mL×2、试剂1:60 mL×2 试剂2:40 mL×1、试剂1:70 mL×1 试剂2:27 mL×1、试剂1:70 mL×2 试剂2:27 mL×2、335测试/盒(日立LST生化分析仪专用)、335测试×2/盒(日立LST生化分析仪专用).
试剂1：15 mL×1 试剂2：5 mL×1、 试剂1：30 mL×2 试剂2：20 mL×1、试剂1：60 mL×1 试剂2：20 mL×1、试剂1：30 mL×3 试剂2：15 mL×2、试剂1：45 mL×2 试剂2：15 mL×2、试剂1：45 mL×2 试剂2：30 mL×1、试剂1：90 mL×1 试剂2：30 mL×1、试剂1：40 mL×3 试剂2：40 mL×1、试剂1：60 mL×2 试剂2：20 mL×2、试剂1：60 mL×2 试剂2：40 mL×1、试剂1：70 mL×1 试剂2：27 mL×1、试剂1：70 mL×2 试剂2：27 mL×2、335测试/盒（日立LST生化分析仪专用）、335测试×2/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20242405253
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1:三羟甲基氨基甲烷缓冲液,聚乙二醇6000,曲拉通X-100,液体生物防腐剂;试剂2:三羟甲基氨基甲烷缓冲液,聚乙二醇6000,羊抗人IgA抗体,液体生物防腐剂.(具体内容详见说明书)

中文

试剂1：三羟甲基氨基甲烷缓冲液，聚乙二醇6000,曲拉通X-100,液体生物防腐剂；试剂2：三羟甲基氨基甲烷缓冲液，聚乙二醇6000,羊抗人IgA抗体,液体生物防腐剂。（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