China NMPA legacy archive 国械注准20243401285Human Immunodeficiency Virus Type 1 (HIV-1) Nucleic Acid Detection Reagent Kit (PCR-Fluorescent Probe Method)
- Device class
- Class III
- Model specifications
- 32 tests/box, 96 tests/box.
- Approval department
- State Drug Administration
- Registration number
- 国械注准20243401285
- Approval date
- July 17, 2024
- Expiry date
- July 16, 2029
- Province/Region
- Shanghai
- Address
- 1189 Qinzhou North Road, Xuhui District, Shanghai
- Production address
- 上海市徐汇区桂平路701号
This product is used to quantitatively detect the content of human immunodeficiency virus type 1 nucleic acid (HIV-1 RNA) in human serum or plasma samples.
该产品用于定量检测人血清或血浆样本中的人类免疫缺陷病毒1型核酸（HIV-1 RNA）的含量。
HIV PCR Reaction Solution A, HIV PCR Reaction Solution B, HIV Internal Standard, Negative Control, HIV Weak Positive Control, HIV Strong Positive Control. (Please refer to the product manual for details)
HIV PCR反应液A、HIV PCR反应液B、HIV内标、阴性对照、HIV弱阳性对照、HIV强阳性对照。（具体内容详见产品说明书）
Store at -20±5°C in the dark for 12 months.
-20±5℃避光储存，有效期为12个月。
- Appendix
- 产品技术要求、说明书
This static archive preserves historical registration fields and translations for Human Immunodeficiency Virus Type 1 (HIV-1) Nucleic Acid Detection Reagent Kit (PCR-Fluorescent Probe Method), registration 国械注准20243401285. It does not establish current authorization or complete current product details.
The default China search uses the separately verified domestic-registration listing, checked daily. Its published listing fields and scope differ from this older snapshot.