Hepatitis B virus nucleic acid detection reagent kit (PCR-fluorescent probe method) - NMPA Registration 国械注准20233400700
Access comprehensive regulatory information for Hepatitis B virus 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20233400700 and owned by Shanghai Fosun LONG March MEDICAL Science Co., Ltd.. The device was approved on June 01, 2023.
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This kit is used for the quantitative detection of Hepatitis B virus (HBV) DNA in human serum or plasma samples in vitro.
本试剂盒用于体外定量检测人血清或血浆样本中的乙型肝炎病毒（Hepatitis B Virus，HBV）DNA。
HBV reaction solution, internal reference, HBV quantitative calibrator S1, HBV quantitative calibrator S2, HBV quantitative calibrator S3, HBV quantitative calibrator S4, HBV critical positive control, HBV strong positive control, negative control. (Please refer to the product manual for details)
HBV反应液，内参，HBV定量校准品S1，HBV定量校准品S2，HBV定量校准品S3，HBV定量校准品S4，HBV临界阳性对照，HBV强阳性对照，阴性对照。（具体内容详见产品说明书）
The kit should be kept away from light and sealed at -20±5°C for a valid period of 12 months.
试剂盒应于-20±5℃的条件下避光、密封保存，有效期12个月。