Steroid hormone controls
- 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 number
- 粤械注准20242401493
- Approval date
- November 06, 2024
- Expiry date
- November 05, 2029
- 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 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
与广州市达瑞生物技术股份有限公司的类固醇激素测定试剂盒(串联质谱法)配套使用,用于定量检测人血清或血浆中睾酮、雄烯二酮、硫酸去氢表雄酮、皮质醇、孕酮、17α-羟孕酮、雌二醇、雌三醇及醛固酮项目的质量控制.
与广州市达瑞生物技术股份有限公司的类固醇激素测定试剂盒（串联质谱法）配套使用，用于定量检测人血清或血浆中睾酮、雄烯二酮、硫酸去氢表雄酮、皮质醇、孕酮、17α-羟孕酮、雌二醇、雌三醇及醛固酮项目的质量控制。
由类固醇激素质控品C1、类固醇激素质控品C2、类固醇激素质控品C3组成.主要成分为去激素胎牛血清,睾酮、雄烯二酮、硫酸去氢表雄酮、皮质醇、孕酮、17α-羟孕酮、雌二醇、雌三醇和醛固酮.
由类固醇激素质控品C1、类固醇激素质控品C2、类固醇激素质控品C3组成。主要成分为去激素胎牛血清，睾酮、雄烯二酮、硫酸去氢表雄酮、皮质醇、孕酮、17α-羟孕酮、雌二醇、雌三醇和醛固酮。
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.开瓶复溶后,质控品在2～8℃有效期为3天,-20±5℃可保存1月,反复冻融不超过4次.
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。开瓶复溶后，质控品在2～8℃有效期为3天，-20±5℃可保存1月，反复冻融不超过4次。
- Appendix
- 产品技术要求、说明书
Access comprehensive regulatory information for Steroid hormone 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 粤械注准20242401493 and owned by Guangzhou Darui Biotechnology Co., Ltd.. The device was approved on November 06, 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.