China NMPA legacy archive 国械注准20253400089Herpes Simplex Virus Type 2 IgM Antibody Test Kit (Magnetic Particle Chemiluminescence Method)
单纯疱疹病毒2型IgM抗体检测试剂盒（磁微粒化学发光法）
Xiamen Innodx BIOTECH Co., Ltd.Class IIINMPAApproved January 10, 2025
Static archiveNMPA · legacy registration snapshot
Device classification
- Device class
- Class III
- Model specifications
- 100 servings/box, 100 servings/box (including calibrators), 100 servings/box (including calibrators and quality controls), 200 servings/box, 200 servings/box (including calibrators), 200 servings/box (including calibrators and quality controls).
- Approval department
- State Drug Administration
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)。
国家药品监督管理局
Registration information
- Registration number
- 国械注准20253400089
- Approval date
- January 10, 2025
- Expiry date
- January 09, 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样品中单纯疱疹病毒2型IgM抗体。
Structure and composition
English
Reagent 1, Reagent 2, Reagent 3, Calibrator 1, Calibrator 2, Quality Control 1, Quality Control 2. (Please refer to the product manual for details)
中文
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。（具体内容详见产品说明书）
Storage conditions and expiration
English
试剂和校准品2～8℃保存，质控品-20±5℃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 2 IgM Antibody Test Kit (Magnetic Particle Chemiluminescence Method), registration 国械注准20253400089. 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.