Human growth hormone (hGH) detection reagent kit (chemiluminescence immunoassay method) - NMPA Registration 粤械注准20252400139
Access comprehensive regulatory information for Human growth hormone (hGH) detection reagent kit (chemiluminescence immunoassay method) in the China medical device market through Pure Global AI's free database. This Class II medical device is registered under NMPA registration number 粤械注准20252400139 and owned by Medcaptain MEDICAL Technology Co., Ltd.. The device was approved on January 23, 2025.
This page provides complete registration details including registrant information, province location (Guangdong), 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.
用于体外定量检测人血清、血浆、全血生长激素（hGH）的含量，临床上主要用于辅助评价垂体功能和非垂体疾病所致的生长激素水平异常，不用于恶性肿瘤患者的动态监测。
磁珠包被物（R1）：包被抗hGH单克隆抗体（小鼠）磁微粒；Tris缓冲液；ProClin 300； 吖啶酯标记物（R2）：标记吖啶酯的抗hGH单克隆抗体（小鼠）；MES 缓冲液；ProClin 300； 反应稀释液（R3）：Tris缓冲液；ProClin 300； hGH校准品C1：生长激素（人源）；Tris缓冲液；ProClin 300； hGH校准品C2：生长激素（人源）；Tris缓冲液；ProClin 300。
储存条件： 试剂及校准品应在2～8℃环境下，竖直向上，密封保存，避免冷冻，有效期14个月。 试剂开瓶使用后，在2～8℃环境下，竖直向上，静置保存，有效期60天。 试剂置于全自动化学发光免疫分析仪（试剂仓温度为2～8℃），有效期30天。 校准品开瓶使用后，盖上盖子密封保存，常温（10～30℃）条件下可保存5天；在2～8℃条件下可保存60天。