雄烯二酮测定试剂盒（化学发光法) - NMPA Registration 苏械注准20252400153
Access comprehensive regulatory information for 雄烯二酮测定试剂盒（化学发光法) in the China medical device market through Pure Global AI's free database. This Class II medical device is registered under NMPA registration number 苏械注准20252400153 and owned by Nanjing Norman Biological Technology Co., Ltd.. The device was approved on January 26, 2025.
This page provides complete registration details including registrant information, province location (Jiangsu), 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.
主要用于体外定量测定人体血清和血浆中的雄烯二酮（ASD）含量。
A磁珠试剂：磁性微粒（≥ 0.1%），标记生物素的雄烯二酮(ASD)抗原偶联物（鼠源）（≥1μg /mL），叠氮钠（0.3%），牛血清白蛋白（≥0.1%）。B吖啶酯标记试剂：标记吖啶酯的特异性雄烯二酮（ASD）抗体（鼠源）（≥0.05μg /mL），叠氮钠（0.3%），酪蛋白（0.25%）。雄烯二酮质控品（选配）：冻干粉，含两种浓度雄烯二酮（ASD）抗原（鼠源）的缓冲液基质（pH=7.4）。质控品水平1的浓度范围为0.35-0.65 ng/mL；水平2的浓度范围为1.4-2.6 ng/mL。雄烯二酮校准品（选配）：冻干粉，含两种浓度雄烯二酮（ASD）抗原（鼠源）的缓冲液基质（pH=7.4）。校准品水平1的浓度范围为0.35-0.65 ng/mL；水平2的浓度范围为1.4-2.6 ng/mL。本试剂盒中的校准品溯源至雄烯二酮国家标准物质100887。另外，还配有射频卡（含标准曲线用于产品定标）。注：不同批号的试剂盒各组分不可互换。
Store stable at 2-8 °C for 15 months, avoid freezing. It is stable for 1 month after storage at 2-8 °C after opening. Controls and calibrators are valid for 15 months. After reconstitution, the control and calibrator are valid for 7 days at 2-8°C.
2-8℃保存稳定15个月，避免冷冻。开瓶后2-8℃保存可稳定1个月。 质控品和校准品有效期为15个月。复溶后，质控品和校准品2-8℃有效期均为7天。