Direct bilirubin assay kit (vanadate oxidation) - NMPA Registration 鄂械注准20252405368

Access comprehensive regulatory information for Direct bilirubin assay kit (vanadate oxidation) 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20252405368 and owned by Wuhan Changli BIOTECH Co., Ltd.. The device was approved on January 17, 2025.

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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NMPA Official Data

Class II

鄂械注准20252405368

Direct bilirubin assay kit (vanadate oxidation)

直接胆红素测定试剂盒（钒酸盐氧化法）

NMPA Registration Number: 鄂械注准20252405368

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Pricing

Intended Use

English

用于体外定量测定人血清、血浆中直接胆红素的含量。

Device Classification

Device Class

Class II

Model Specifications

试剂1：20 mL×1 试剂2：5 mL×1、试剂1：60 mL×1 试剂2：15 mL×1、试剂1：40 mL×2 试剂2：20 mL×1、试剂1：80 mL×1 试剂2：20 mL×1、试剂1：30 mL×4 试剂2：15 mL×2、试剂1：40 mL×3 试剂2：15 mL×2、试剂1：40 mL×3 试剂2：30 mL×1、试剂1：60 mL×2 试剂2：15 mL×2、试剂1：60 mL×2 试剂2：30 mL×1、试剂1：40 mL×4 试剂2：20 mL×2、试剂1：40 mL×4 试剂2：40 mL×1、试剂1：80 mL×2 试剂2：20 mL×2、试剂1：80 mL×2 试剂2：40 mL×1、试剂1：60 mL×4 试剂2：20 mL×3、试剂1：60 mL×4 试剂2：60 mL×1、试剂1：100 mL×4 试剂2：100 mL×1、504测试/盒（日立LST生化分析仪专用）、504测试×4/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20252405368

Approval Date

January 17, 2025

Expiry Date

January 16, 2030

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：酒石酸缓冲液，曲拉通X-100；试剂2：磷酸盐缓冲液，偏钒酸钠。（具体内容详见说明书）

Storage Conditions and Expiration

English

试剂在2℃～8℃避光环境密封保存中的有效期为12个月，严禁冷冻。

Additional Information

Appendix

产品技术要求、说明书