Rubella Virus IgG Antibody Assay Kit (Magnetic Particle Chemiluminescence Method)
- 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).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 number
- 国械注准20243401310
- Approval date
- July 23, 2024
- Expiry date
- July 22, 2029
- Name
- Xiamen Innodx BIOTECH Co., Ltd.厦门万泰凯瑞生物技术有限公司
- Province/Region
- Fujian福建
- Address
- 2nd floor, No. 124, Xinyuan Road, Xinyang Street, Haicang District, Xiamen厦门市海沧区新阳街道新园路124号2楼
- 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
This kit is used for the qualitative detection of rubella virus IgG antibodies in human serum and plasma.
本试剂盒用于定性检测人血清和血浆中的风疹病毒IgG抗体。
Reagent 1, Reagent 2, Reagent 3, Calibrator 1, Calibrator 2, Quality Control 1, Quality Control 2, Quality Control 3. (Please refer to the product manual for details)
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、质控品3。（具体内容详见产品说明书）
Reagents and calibrators are stored at 2~8°C, and quality controls are stored at <-15°C, with an expiration date of 12 months.
试剂和校准品2～8℃保存，质控品＜-15℃保存，有效期12个月。
- Appendix
- 产品技术要求、说明书
Access comprehensive regulatory information for Rubella Virus IgG Antibody Assay Kit (Magnetic Particle Chemiluminescence Method) 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20243401310 and owned by Xiamen Innodx BIOTECH Co., Ltd.. The device was approved on July 23, 2024.
This page provides complete registration details including registrant information, province location (Fujian), 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.