Pure Global

单纯疱疹病毒1+2型IgM抗体检测试剂盒(化学发光免疫分析法) - NMPA Registration 国械注准20253400095

Access comprehensive regulatory information for 单纯疱疹病毒1+2型IgM抗体检测试剂盒(化学发光免疫分析法) in the China medical device market through Pure Global AI's free database. This Class III medical device is registered under NMPA registration number 国械注准20253400095 and owned by Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. The device was approved on January 10, 2025.

This page provides complete registration details including registrant information, province location (Guangdong), 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.

Free Database
Powered by Pure Global AI
NMPA Official Data
Class III
国械注准20253400095
单纯疱疹病毒1+2型IgM抗体检测试剂盒(化学发光免疫分析法)
NMPA Registration Number: 国械注准20253400095
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
Intended Use
English

本产品用于体外定性检测人血清或血浆中的单纯疱疹病毒1型和2型特异性IgM抗体。

Device Classification
Device Class
Class III
Model Specifications
2×50 人份/盒(含校准品)、 2×100 人份/盒(含校准品)
Approval Department
State Drug Administration
国家药品监督管理局
Registration Information
Registration Number
国械注准20253400095
Approval Date
January 10, 2025
Expiry Date
January 09, 2030
Registrant
Name
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
深圳迈瑞生物医疗电子股份有限公司
Province/Region
Guangdong
广东
Address
Floor 1-4, Mindray Building, Keji South 12th Road, High-tech Industrial Park, Nanshan District, Shenzhen
深圳市南山区高新技术产业园区科技南十二路迈瑞大厦1-4层
Production Facility
Production Address
深圳市光明新区南环大道1203号
Structure and Composition
English

磁珠包被物(Ra), 酶标记物(Rb), 样本处理液(Rc), 测试稀释液(Rd), 校准品C0, 校准品C1和条码。(具体内容详见产品说明书)

Storage Conditions and Expiration
English

Store at 2~8°C, valid for 18 months.

中文

2~8℃保存,有效期18个月。

Additional Information
Appendix
产品技术要求、说明书