China NMPA legacy archive 国械注准20243401942Rubella Virus IgM Antibody Test 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).
- Approval department
- State Drug Administration
- Registration number
- 国械注准20243401942
- Approval date
- September 29, 2024
- Expiry date
- September 28, 2029
- Province/Region
- Fujian
- Address
- 2nd floor, No. 124, Xinyuan Road, Xinyang Street, Haicang District, Xiamen
- 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 IgM 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IgM抗体。
Reagent 1, Reagent 2, Reagent 3, Calibrator 1, Calibrator 2, Quality Control 1, Quality Control 2. (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。（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
This static archive preserves historical registration fields and translations for Rubella Virus IgM Antibody Test Kit (Magnetic Particle Chemiluminescence Method), registration 国械注准20243401942. It does not establish current authorization or complete current product details.
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