Whole Blood Drug Concentration Composite Quality Control
- Device class
- Class II
- Model specifications
- 2times;0.5mL,2times; 1 mL (lyophilized, 2 levels)2times;0.5mL，2times;1mL(冻干品，2水平)
- Approval department
- Beijing Municipal Drug Administration北京市药品监督管理局
- Registration number
- 京械注准20232400462
- Approval date
- July 05, 2023
- Expiry date
- July 04, 2028
- Name
- Beijing Diagreat Biotechnologies Co., Ltd.北京丹大生物技术有限公司
- Province/Region
- Beijing北京
- Address
- 101, 1st to 3rd floor, Building 19, No. 2 Huanke Middle Road, Beijing Economic and Technological Development Zone (Tongzhou), Beijing北京市北京经济技术开发区(通州)环科中路2号院19号楼1至3层101
- Production address
- 北京市通州区环科中路2号院19号楼-1至3层
Used in conjunction with our drug concentration detection kit for in-room quality control of tacrolimus and cyclosporine 2 products.
与本公司药物浓度检测试剂盒配套使用，用于他克莫司和环孢霉素2个产品的室内质量控制。
Product components content Whole blood matrix ＞50%(V/V) Proclin 300 0.02% Target concentration FK506: Level 1:1-10ng/mL; Level 2: 10-30 ng/mL; CsA: Level 1: 40-300 ng/mL; Level 2: 300-800 ng/mL; Note: The quality control assignment is batch specific, and the target value of each batch is detailed in the target value list.
产品组分 含量 全血基质 ＞50%（V/V） Proclin 300 0.02% 目标浓度 FK506：水平1：1-10ng/mL； 水平2：10-30 ng/mL； CsA：水平1：40-300ng/mL； 水平2：300-800 ng/mL； 注：质控品赋值具有批特异性，每批次靶值详见靶值单。
The reagent is protected from light storage at 2 °C ~ 8 °C
试剂在2℃～8℃条件下避光存
- Appendix
- 产品技术要求、说明书
Access comprehensive regulatory information for Whole Blood Drug Concentration Composite Quality Control 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20232400462 and owned by Beijing Diagreat Biotechnologies Co., Ltd.. The device was approved on July 05, 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.