Total cholesterol test kit (CHOD-PAP method)
- Device class
- Class II
- Model specifications
- 728测试/盒;690测试/盒;试剂1:2;55mL、试剂2:2;22mL;试剂1:2;53mL、试剂2:2;21mL.质控品(水平1):1;1mL;质控品(水平2):1;1mL.728测试/盒；690测试/盒；试剂1:2;55mL、试剂2:2;22mL；试剂1:2;53mL、试剂2:2;21mL。质控品（水平1）：1;1mL；质控品（水平2）：1;1mL。
- Approval department
- Beijing Municipal Drug Administration北京市药品监督管理局
- Registration number
- 京械注准20242400703
- Approval date
- November 12, 2024
- Expiry date
- November 11, 2029
- Name
- Beijing Strong Biotechnologies,Inc.北京九强生物技术股份有限公司
- Province/Region
- Beijing北京
- Address
- 5th floor, Kuanyi Building, No. 15 Huayuan East Road, Haidian District, Beijing北京市海淀区花园东路15号旷怡大厦5层
- Production address
- 北京市怀柔区雁栖经济开发区雁栖北二街15号
This kit is used for the in vitro quantitative determination of total cholesterol (CHO) in human serum or plasma.
本试剂盒用于体外定量测定人血清或血浆中总胆固醇（CHO）的含量。
试剂成分浓度试剂1:Goodrsquo;s缓冲液胆固醇脂酶过氧化物酶4-氨基安替比林60mmol/L0.3-2.0KU/L1.5-3.0KU/L1.8mmol/L试剂2:Goodrsquo;s缓冲液胆固醇氧化酶N-乙基-N-(3-甲苯)-N-琥珀酰乙二胺60mmol/L0.8-2.0KU/L1.5mmol/L质控品(冻干粉),2水平血清目标浓度范围ge;30%水平1:3.40～5.00mmol/L水平2:5.01～8.00mmol/L注:质控品靶值批特异,详见靶值单;
试剂成分浓度试剂1：Goodrsquo;s缓冲液胆固醇脂酶过氧化物酶4-氨基安替比林60mmol/L0.3-2.0KU/L1.5-3.0KU/L1.8mmol/L试剂2：Goodrsquo;s缓冲液胆固醇氧化酶N-乙基-N-（3-甲苯）-N-琥珀酰乙二胺60mmol/L0.8-2.0KU/L1.5mmol/L质控品（冻干粉），2水平血清目标浓度范围ge;30%水平1：3.40～5.00mmol/L水平2：5.01～8.00mmol/L注：质控品靶值批特异，详见靶值单；
2℃~ 8℃密封避光保存,有效期18个月.
2℃~ 8℃密封避光保存，有效期18个月。
Access comprehensive regulatory information for Total cholesterol test kit (CHOD-PAP method) 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20242400703 and owned by Beijing Strong Biotechnologies,Inc.. The device was approved on November 12, 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.