China NMPA legacy archive 京械注准20242400322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
- Registration number
- 京械注准20242400322
- Approval date
- June 19, 2024
- Expiry date
- June 18, 2029
- Province/Region
- Beijing
- Address
- 107, 1st floor, Building 1, No. 20 Chuangzhan Road, Daxing District, Beijing
- 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。
This static archive preserves historical registration fields and translations for 胰蛋白酶原2测定试剂盒（胶乳免疫比浊法）, registration 京械注准20242400322. It does not establish current authorization or complete current product details.
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