全段甲状旁腺激素（iPTH）测定试剂盒（化学发光免疫分析法） - NMPA Registration 粤械注准20252400141
Access comprehensive regulatory information for 全段甲状旁腺激素（iPTH）测定试剂盒（化学发光免疫分析法） in the China medical device market through Pure Global AI's free database. This Class II medical device is registered under NMPA registration number 粤械注准20252400141 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、血浆和全血样本中全段甲状旁腺激素（iPTH）的含量，临床上主要用于评价甲状旁腺功能。
磁珠包被物（R1）：包被抗PTH抗体（山羊）的磁微粒；Tris缓冲液；ProClin 300； 吖啶酯标记物（R2）：标记吖啶酯的抗PTH抗体（山羊）；MES 缓冲液；ProClin 300； iPTH校准品C1：iPTH（重组）；Tris缓冲液；ProClin 300； iPTH校准品C2：iPTH（重组）；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。