Progesterone assay kit (chemiluminescence) - NMPA Registration 川械注准20242400313
Access comprehensive regulatory information for Progesterone assay kit (chemiluminescence) 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20242400313 and owned by Sichuan Orienter Biotechnology Co., Ltd.. The device was approved on November 26, 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.
This kit is used for the in vitro quantitative determination of the concentration of progesterone (Progesterone, Prog) in human serum or plasma samples.
本试剂盒用于体外定量测定人血清或血浆样本中孕酮（Progesterone，Prog）的浓度。
试剂1(R1):免疫磁珠;试剂2(R2):酶结合物;试剂3(R3):分析缓冲液 ;Prog校准品;Prog质控品.(具体内容详见产品说明书)
试剂1（R1）：免疫磁珠；试剂2（R2）：酶结合物；试剂3（R3）：分析缓冲液 ；Prog校准品；Prog质控品。（具体内容详见产品说明书）
2°C~8°C sealed and protected from light, and the validity period is 15 months.
2℃～8℃密闭避光保存有效期为15个月。