China NMPA legacy archive 国械注准20253400211Herpes simplex virus type 1 IgG antibody test kit (magnetic particle chemiluminescence method)
单纯疱疹病毒1型IgG抗体检测试剂盒（磁微粒化学发光法）
Xiamen Innodx BIOTECH Co., Ltd.Class IIINMPAApproved January 20, 2025
Static archiveNMPA · legacy registration snapshot
Device classification
- Device class
- Class III
- Model specifications
- 100人份/盒，100人份/盒（含校准品），100人份/盒（含校准品、质控品），200人份/盒，200人份/盒（含校准品），200人份/盒（含校准品、质控品）。
- Approval department
- State Drug Administration
国家药品监督管理局
Registration information
- Registration number
- 国械注准20253400211
- Approval date
- January 20, 2025
- Expiry date
- January 19, 2030
Registrant
- Province/Region
- Fujian
- Address
- 2nd floor, No. 124, Xinyuan Road, Xinyang Street, Haicang District, Xiamen
福建
厦门市海沧区新阳街道新园路124号2楼
Production facility
- Production address
- 厦门市海沧区新阳街道新园路120号6层4单元、126号（1楼、4楼A区）、130号4号楼（A区、B区）和5号楼
Intended use
English
本试剂用于定性检测人血清和血浆中单纯疱疹病毒1型IgG抗体。
Structure and composition
English
试剂1、试剂2、试剂3、校准品1、校准品2、质控品1、质控品2。（具体内容详见说明书）
Storage conditions and expiration
English
Reagents and calibrators are stored at 2~8°C, and quality controls are stored at <-15°C, with an expiration date of 12 months.
中文
试剂和校准品2～8℃保存，质控品＜-15℃保存，有效期12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 Herpes simplex virus type 1 IgG antibody test kit (magnetic particle chemiluminescence method), registration 国械注准20253400211. 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.