胰蛋白酶原2测定试剂盒（胶乳免疫比浊法）
- Device class
- Class II
- Model specifications
- 组分规格试剂R148mL;2/R212mL;2R148mL;1/R212mL;1R124mL;1/R26mL;1R18mL;1/R22mL;1校准品(选配)0.5mL;5质控品(选配)0.5mL;2
- Approval department
- Beijing Municipal Drug Administration北京市药品监督管理局
- Registration number
- 京械注准20242400322
- Approval date
- June 19, 2024
- Expiry date
- June 18, 2029
- Name
- Beijing Beier Bioengineering Co., Ltd.北京贝尔生物工程股份有限公司
- Province/Region
- Beijing北京
- Address
- 107, 1st floor, Building 1, No. 20 Chuangzhan Road, Daxing District, Beijing北京市大兴区创展路20号院1号楼1层107
- Production address
- 北京市大兴区创展路20号院
本产品用于体外定量测定人尿液样本中胰蛋白酶原2（Trp2）的含量。
类型主要成分浓度试剂1（R1）PBS缓冲液50mMProclin3001mL/L试剂2（R2）标记胰蛋白酶原2抗体的胶乳溶液0.25%Proclin3001mL/L校准品(选配)人胰蛋白酶原2抗原5水平，液体，基质溶液为20mMPBS、1%海藻糖、0.5%蔗糖、0.5%BSA，目标浓度范围为S10.0ng/mL、S230.0~200.0ng/mL、S3250.0~800.0ng/mL、S41000.0~2000.0ng/mL、S52500.0~4000.0ng/mL浓度批特异，见靶值单Proclin3001mL/L质控品(选配)人胰蛋白酶原2抗原2水平，液体，基质溶液为20mMPBS、1%海藻糖、0.5%蔗糖、0.5%BSA，目标浓度范围为Q130.0~250.0ng/mL、Q2400.0~1000.0ng/mL浓度批特异，见靶值单Proclin3001mL/L
The kit is stored at 2~8 °C and is valid for 12 months.
试剂盒保存于2～8℃，有效期12个月。
Access comprehensive regulatory information for 胰蛋白酶原2测定试剂盒（胶乳免疫比浊法） 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20242400322 and owned by Beijing Beier Bioengineering Co., Ltd.. The device was approved on June 19, 2024.
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.