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Immune suppressant quality control product - NMPA Registration 粤械注准20242401552

Access comprehensive regulatory information for Immune suppressant quality control product 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20242401552 and owned by Guangzhou Darui Biotechnology Co., Ltd.. The device was approved on November 21, 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.

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Class II
粤械注准20242401552
Immune suppressant quality control product
免疫抑制剂质控品
NMPA Registration Number: 粤械注准20242401552
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Pricing
Intended Use
English

与广州市达瑞生物技术股份有限公司的四种免疫抑制剂测定试剂盒(串联质谱法)配套使用,用于定量检测人全血或血清中霉酚酸以及人全血中他克莫司、雷帕霉素和环孢霉素项目的质量控制.

中文

与广州市达瑞生物技术股份有限公司的四种免疫抑制剂测定试剂盒(串联质谱法)配套使用,用于定量检测人全血或血清中霉酚酸以及人全血中他克莫司、雷帕霉素和环孢霉素项目的质量控制。

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20242401552
Approval Date
November 21, 2024
Expiry Date
November 20, 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

由免疫抑制剂质控品C1、免疫抑制剂质控品C2、免疫抑制剂质控品C3组成.主要成分为脱纤维绵羊全血,他克莫司、雷帕霉素、环孢霉素和霉酚酸.

中文

由免疫抑制剂质控品C1、免疫抑制剂质控品C2、免疫抑制剂质控品C3组成。主要成分为脱纤维绵羊全血,他克莫司、雷帕霉素、环孢霉素和霉酚酸。

Storage Conditions and Expiration
English

2~8℃保存,质控品有效期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个月,反复冻融不超过4次.

中文

2~8℃保存,质控品有效期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个月,反复冻融不超过4次。

Additional Information
Appendix
产品技术要求、说明书