Catecholamines and their metabolite calibracents - NMPA Registration 京械注准20232400012
Access comprehensive regulatory information for Catecholamines and their metabolite calibracents in the China medical device market through Pure Global AI's free database. This Class II medical device is registered under NMPA registration number 京械注准20232400012 and owned by Beijing BGI-GBI Biotech Co., Ltd.. The device was approved on January 04, 2023.
This page provides complete registration details including registrant information, province location (Beijing), 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.
It is used in conjunction with the sample release agent (catecholamine-magnetic bead method) and applicable instruments produced by the company for the calibration of the detection system of six indicators, including methoxyepinephrine (MN), methoxynorepinephrine (NMN), 3-methoxytyramine (3-MT), epinephrine (E), norepinephrine (NE), and dopamine (DA).
与本公司生产的样本释放剂（儿茶酚胺-磁珠法）及适用仪器配套使用，用于甲氧基肾上腺素（MN）、甲氧基去甲肾上腺素（NMN）、3-甲氧基酪胺（3-MT）、肾上腺素（E）、去甲肾上腺素（NE）、多巴胺（DA）共6项指标的检测系统校准。
Note: The calibrator is lot specific, and the specific concentration is shown in the target value list.
备注：校准品具有批特异性，具体浓度见靶值单。
Avoid unopened kits below -18 °C
未开封试剂盒在-18℃以下避