China NMPA legacy archive 国械注准20243401663Cytomegalovirus IgG antibody test kit (magnetic microparticle 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20243401663
- Approval date
- September 02, 2024
- Expiry date
- September 01, 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
It is used for the qualitative detection of cytomegalovirus IgG antibodies in human serum and plasma.
用于定性检测人血清和血浆中的巨细胞病毒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 -20±5°C; Valid for 12 months.
试剂和校准品2～8℃保存，质控品-20±5℃保存；有效期12个月。
- Appendix
- 产品技术要求、说明书
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