Pure Global

儿茶酚胺及代谢物质控品 - NMPA Registration 粤械注准20242401537

Access comprehensive regulatory information for 儿茶酚胺及代谢物质控品 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20242401537 and owned by Guangzhou Darui Biotechnology Co., Ltd.. The device was approved on November 15, 2024.

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.

Free Database
Powered by Pure Global AI
NMPA Official Data
Class II
粤械注准20242401537
儿茶酚胺及代谢物质控品
NMPA Registration Number: 粤械注准20242401537
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
Intended Use
English

与广州市达瑞生物技术股份有限公司的血儿茶酚胺及代谢物测定试剂盒(串联质谱法)配套使用,用于定量检测人血清或血浆中肾上腺素、去甲肾上腺素、多巴胺、甲氧基肾上腺素、甲氧基去甲肾上腺素、3-甲氧基酪胺项目的质量控制.

中文

与广州市达瑞生物技术股份有限公司的血儿茶酚胺及代谢物测定试剂盒(串联质谱法)配套使用,用于定量检测人血清或血浆中肾上腺素、去甲肾上腺素、多巴胺、甲氧基肾上腺素、甲氧基去甲肾上腺素、3-甲氧基酪胺项目的质量控制。

Device Classification
Device Class
Class II
Model Specifications
3瓶,1.0mL/瓶(冻干品复溶体积)
3瓶,1.0mL/瓶(冻干品复溶体积)
Approval Department
Guangdong Provincial Drug Administration
广东省药品监督管理局
Registration Information
Registration Number
粤械注准20242401537
Approval Date
November 15, 2024
Expiry Date
November 14, 2029
Registrant
Name
Guangzhou Darui Biotechnology Co., Ltd.
广州市达瑞生物技术股份有限公司
Province/Region
Guangdong
广东
Address
No. 6 Lizhishan Road, Guangzhou High-tech Industrial Development Zone, No. 2 No. 404
广州市高新技术产业开发区荔枝山路6号自编2号404
Production Facility
Production Address
广州高新技术产业开发区荔枝山路6号,1号楼4楼401-408室;2号楼1楼、4楼
Structure and Composition
English

由儿茶酚胺及代谢物质控品C1、儿茶酚胺及代谢物质控品C2、儿茶酚胺及代谢物质控品C3组成.主要成分为去激素胎牛血清、肾上腺素、去甲肾上腺素、多巴胺、甲氧基肾上腺素、甲氧基去甲肾上腺素和3-甲氧基酪胺.

中文

由儿茶酚胺及代谢物质控品C1、儿茶酚胺及代谢物质控品C2、儿茶酚胺及代谢物质控品C3组成。主要成分为去激素胎牛血清、肾上腺素、去甲肾上腺素、多巴胺、甲氧基肾上腺素、甲氧基去甲肾上腺素和3-甲氧基酪胺。

Storage Conditions and Expiration
English

2~8℃保存,质控品有效期为12个月.建议贮藏时质控品直立放置并盖好瓶盖.质控品开瓶复溶后,在2~8℃有效期为3天,在-20±5℃可保存1个月,反复冻融不超过4次.

中文

2~8℃保存,质控品有效期为12个月。建议贮藏时质控品直立放置并盖好瓶盖。质控品开瓶复溶后,在2~8℃有效期为3天,在-20±5℃可保存1个月,反复冻融不超过4次。

Additional Information
Appendix
产品技术要求、说明书