China NMPA legacy archive 国械注准20253400098

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

Name: II型单纯疱疹病毒IgM抗体（HSV-II IgM）检测试剂盒（化学发光免疫分析法） — NMPA archive 国械注准20253400098
Creator: Guangzhou Kangrun Biotechnology Co., Ltd.
Keywords: II型单纯疱疹病毒IgM抗体（HSV-II IgM）检测试剂盒（化学发光免疫分析法）, II型单纯疱疹病毒IgM抗体（HSV-II IgM）检测试剂盒（化学发光免疫分析法）, 国械注准20253400098, Class III, NMPA registration

Guangzhou Kangrun Biotechnology Co., Ltd.Class IIINMPAApproved January 10, 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20253400098
Approval date: January 10, 2025
Expiry date: January 09, 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II型单纯疱疹病毒IgM抗体。

Structure and composition

English

HSV-II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-II IgM阴性对照、HSV-II IgM阳性对照、复溶液、阴阳性对照信息卡。（具体内容详见产品说明书）

Storage conditions and expiration

English

Store at 2~8 °C in the dark, valid for 18 months.

中文

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 II型单纯疱疹病毒IgM抗体（HSV-II IgM）检测试剂盒（化学发光免疫分析法）, registration 国械注准20253400098. 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.