Human Immunodeficiency Virus Type 1 (HIV-1) Nucleic Acid Detection Reagent Kit (PCR-Fluorescent Probe Method) - NMPA Registration 国械注准20243401285
Access comprehensive regulatory information for Human Immunodeficiency Virus Type 1 (HIV-1) Nucleic Acid Detection Reagent Kit (PCR-Fluorescent Probe 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20243401285 and owned by Shanghai Kehua Bio-Engineering Co., Ltd.. The device was approved on July 17, 2024.
This page provides complete registration details including registrant information, province location (Shanghai), 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.
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。