Human 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.试剂 1×25 人份/盒 阴性对照 1 水平×1支×2.0mL 阳性对照 1 水平×1支×2.0mL 质控品 3水平×1支×4.0mL；试剂 1×50 人份/盒 阴性对照 1 水平×1支×2.0mL 阳性对照 1 水平×1支×2.0mL 质控品 3水平×1支×4.0mL；试剂 1×100 人份/盒 阴性对照 1 水平×1支×2.0mL 阳性对照 1 水平×1支×2.0mL 质控品 3水平×1支×4.0mL。
- Approval department
- State Drug Administration国家药品监督管理局
- Registration number
- 国械注准20243401859
- Approval date
- September 19, 2024
- Expiry date
- September 18, 2029
- Name
- Zybio Inc.中元汇吉生物技术股份有限公司
- Province/Region
- Chongqing重庆
- Address
- Floor 1-4, Building 30, No. 6 Taikang Road, Area C, Jianqiao Industrial Park, Dadukou District, Chongqing重庆市大渡口区建桥工业园C区太康路6号30栋第1-4层
- 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
Access comprehensive regulatory information for Human Immunodeficiency Virus Antigen Antibody Test 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20243401859 and owned by Zybio Inc.. The device was approved on September 19, 2024.
This page provides complete registration details including registrant information, province location (Chongqing), 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.