Catecholamines and their metabolite controls
- Device class
- Class II
- Model specifications
- 1.1 Packaging specifications Low-value controls: 1×1.5mL (dry powder, reconstituted volume), high-value controls: 1×1.5mL (dry powder, reconstituted volume); Low-value controls: 2×1.5mL (dry powder, reconstituted volume), high-value controls: 2×1.5mL (dry powder, reconstituted volume).1.1包装规格 低值质控品：1×1.5mL (干粉，复溶体积)，高值质控品：1×1.5mL (干粉，复溶体积)； 低值质控品：2×1.5mL (干粉，复溶体积)，高值质控品：2×1.5mL (干粉，复溶体积)。
- Approval department
- Beijing Municipal Drug Administration北京市药品监督管理局
- Registration number
- 京械注准20232400015
- Approval date
- January 04, 2023
- Expiry date
- January 03, 2028
- Name
- Beijing BGI-GBI Biotech Co., Ltd.北京华大吉比爱生物技术有限公司
- Province/Region
- Beijing北京
- Address
- Room 236, Room 237, Building 1, No. 538, Yongfeng Tun, Haidian District, Beijing北京市海淀区永丰屯538号1号楼236、237室
- Production address
- 北京市顺义区临空经济核心区裕华路28号6号4层，8号2层西侧，12号3层西，12号1层西侧
It is used in conjunction with the sample release agent (catecholamine-magnetic bead method) and applicable instruments produced by the company for indoor quality control 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项指标的室内质量控制。
Note: The quality control is batch specific, and the specific concentration is shown in the target value list.
备注：质控品具有批特异性，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
- Appendix
- 产品技术要求、说明书
Access comprehensive regulatory information for Catecholamines and their metabolite controls 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20232400015 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.