25-Hydroxy Vitamin D Test Kit (Direct Chemiluminescence Method) - NMPA Registration 川械注准20242400328
Access comprehensive regulatory information for 25-Hydroxy Vitamin D Test Kit (Direct Chemiluminescence 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 川械注准20242400328 and owned by Maccura Biotechnology Co., Ltd.. The device was approved on December 04, 2024.
This page provides complete registration details including registrant information, province location (Sichuan), 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.
本品用于体外定量测定人血清或血浆样本中25-羟基维生素D的浓度.
本品用于体外定量测定人血清或血浆样本中25-羟基维生素D的浓度。
试剂盒包含试剂1(R1):磁微粒、鼠抗25-羟基维生素D单克隆抗体;试剂2(R2):吖啶酯标记的鸡抗25-羟基维生素D单克隆抗体;试剂3(R3):含柠檬酸钠的分析缓冲液;校准1(Cal1):25-羟基维生素D抗原;校准2(Cal2):25-羟基维生素D抗原;水平1(QC1):25-羟基维生素D抗原;水平2(QC2):25-羟基维生素D抗原.(具体内容详见产品说明书)
试剂盒包含试剂1（R1）：磁微粒、鼠抗25-羟基维生素D单克隆抗体；试剂2（R2）：吖啶酯标记的鸡抗25-羟基维生素D单克隆抗体；试剂3（R3）：含柠檬酸钠的分析缓冲液；校准1（Cal1）：25-羟基维生素D抗原；校准2（Cal2）：25-羟基维生素D抗原；水平1（QC1）:25-羟基维生素D抗原；水平2（QC2）:25-羟基维生素D抗原。（具体内容详见产品说明书）
本品于2℃～8℃密闭避光保存,严禁冷冻,有效期为6个月.
本品于2℃～8℃密闭避光保存，严禁冷冻，有效期为6个月。