China NMPA legacy archive 国械注准20243401859Human Immunodeficiency Virus Antigen Antibody Test Kit (Magnetic Particle Chemiluminescence Method)
- Device class
- Class III
- Model specifications
- Reagent 1×25 servings/box Negative Control 1 Level × 1 × 2.0mL Positive Control 1 Level × 1 × 2.0mL Control 3 Level × 1 × 4.0mL; Reagent 1×50 servings/box Negative Control 1 Level × 1 × 2.0mL Positive Control 1 Level × 1 × 2.0mL Control 3 Level × 1 × 4.0mL; Reagent 1×100 servings/box Negative Control 1 Level × 1 × 2.0mL Positive Control 1 Level × 1 × 2.0mL Control 3 Level × 1 × 4.0mL.
- Approval department
- State Drug Administration
- Registration number
- 国械注准20243401859
- Approval date
- September 19, 2024
- Expiry date
- September 18, 2029
- Province/Region
- Chongqing
- Address
- Floor 1-4, Building 30, No. 6 Taikang Road, Area C, Jianqiao Industrial Park, Dadukou District, Chongqing
- Production address
- 重庆市大渡口区建桥工业园C区太康路10号27-28栋第1-4层；重庆市大渡口区建桥工业园C区太康路5号38栋第1-5层
This product is used for the qualitative detection of human immunodeficiency virus p24 antigen and human immunodeficiency virus type 1 (group M and O)/type 2 antibody in human serum and plasma samples in vitro.
本产品用于体外定性检测人血清和血浆样本中的人类免疫缺陷病毒p24抗原和人类免疫缺陷病毒1型（M、O组）/2型抗体。
Sample Treatment Solution (R1), Reagent 2 (R2), Test Diluent (R3), Magnetic Particles (M), Negative Control, Positive Control, Control 1 (Negative), Control 2 (Positive), and Control 3 (Positive). (Please refer to the product manual for details).
样本处理液（R1）、试剂2（R2）、测试稀释液（R3）、磁微粒（M）、阴性对照、阳性对照、质控品1（阴性）、质控品2（阳性）和质控品3（阳性）。（具体内容详见产品说明书）。
The kit is stored at 2~8 °C and is valid for 12 months.
试剂盒在2～8℃保存，有效期12个月。
- Appendix
- 产品技术要求、说明书
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