China NMPA legacy archive 京械注准20242400703Total 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.
- Approval department
- Beijing Municipal Drug Administration
- Registration number
- 京械注准20242400703
- Approval date
- November 12, 2024
- Expiry date
- November 11, 2029
- Province/Region
- Beijing
- Address
- 5th floor, Kuanyi Building, No. 15 Huayuan East Road, Haidian District, Beijing
- 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。
This static archive preserves historical registration fields and translations for Total cholesterol test kit (CHOD-PAP method), registration 京械注准20242400703. It does not establish current authorization or complete current product details.
The default China search uses the separately verified domestic-registration listing, checked daily. Its published listing fields and scope differ from this older snapshot.