China NMPA legacy archive 国械注准20253400215

I型单纯疱疹病毒IgM抗体（HSV-I IgM）检测试剂盒（化学发光免疫分析法）

Name: I型单纯疱疹病毒IgM抗体（HSV-I IgM）检测试剂盒（化学发光免疫分析法） — NMPA archive 国械注准20253400215
Creator: Guangzhou Kangrun Biotechnology Co., Ltd.
Keywords: I型单纯疱疹病毒IgM抗体（HSV-I IgM）检测试剂盒（化学发光免疫分析法）, I型单纯疱疹病毒IgM抗体（HSV-I IgM）检测试剂盒（化学发光免疫分析法）, 国械注准20253400215, Class III, NMPA registration

Guangzhou Kangrun Biotechnology Co., Ltd.Class IIINMPAApproved January 20, 2025

Static archiveNMPA · legacy registration snapshot

Device classification

Device class: Class III
Model specifications: 100 servings/box
Approval department: State Drug Administration

Registration information

Registration number: 国械注准20253400215
Approval date: January 20, 2025
Expiry date: January 19, 2030

Registrant

Name: Guangzhou Kangrun Biotechnology Co., Ltd.
Province/Region: Guangdong
Address: No. 6 Nanjiang 2nd Road, Zhujiang Street, Nansha District, Guangzhou, 9 buildings (6# building) 13 floors

Production facility

Production address: 广州市南沙区珠江街南江二路6号自编7栋（4#楼）1-3层、401、5-6层

Intended use

English

本试剂盒适用于体外定性检测人血清或血浆中的I型单纯疱疹病毒IgM抗体。

Structure and composition

English

试剂盒由HSV-I磁珠包被物（R1）、抗人IgM抗体吖啶酯标记物（R2）、反应缓冲液（R3）、HSV-I IgM阴性对照、HSV-I IgM阳性对照、复溶液和阴阳性对照信息卡组成。（具体信息详见产品说明书）

Storage conditions and expiration

English

未开封试剂，2～8℃避光保存，有效期18个月。

Additional information

Appendix: 产品技术要求、说明书

About this record

This static archive preserves historical registration fields and translations for I型单纯疱疹病毒IgM抗体（HSV-I IgM）检测试剂盒（化学发光免疫分析法）, registration 国械注准20253400215. It does not establish current authorization or complete current product details.

The default China search uses the separately verified domestic-registration listing, checked daily. Its published listing fields and scope differ from this older snapshot.