京械注准20152400777

Total cholesterol test kit (CHOD-PAP method)

总胆固醇测定试剂盒（CHOD-PAP法）

Beijing Beijian Xinchuangyuan Biotechnology Co., Ltd.·Class II·NMPA·Approved March 20, 2020

Device classification

Device class: Class II
Model specifications: 40ml;40mltimes;2;40mltimes;3;40mltimes;4;40mltimes;5; 40mltimes;6;40mltimes;7;40mltimes;8;40mltimes;9;40mltimes;10; 50ml;50mltimes;2;50mltimes;3;50mltimes;4;50mltimes;5; 50mltimes;6;50mltimes;7;50mltimes;8;50mltimes;9;50mltimes;10; 60ml;60mltimes;2;60mltimes;3;60mltimes;4;60mltimes;5; 60mltimes;6;60mltimes;7;60mltimes;8;60mltimes;9;60mltimes;10; 70ml;70mltimes;2;70mltimes;3;70mltimes;4;70mltimes;5; 70mltimes;6;70mltimes;7;70mltimes;8;70mltimes;9;70mltimes;10; 80ml;80mltimes;2;80mltimes;3;80mltimes;4;80mltimes;5; 80mltimes;6;80mltimes;7;80mltimes;8;80mltimes;9;80mltimes;10; 90ml;90mltimes;2;90mltimes;3;90mltimes;4;90mltimes;5; 90mltimes;6;90mltimes;7;90mltimes;8;90mltimes;9;90mltimes;10; 100ml;100mltimes;2;100mltimes;3;100mltimes;4;100mltimes;5; 100mltimes;6;100mltimes;7;100mltimes;8;100mltimes;9;100mltimes;10.
40ml；40mltimes;2；40mltimes;3；40mltimes;4；40mltimes;5； 40mltimes;6；40mltimes;7；40mltimes;8；40mltimes;9；40mltimes;10； 50ml；50mltimes;2；50mltimes;3；50mltimes;4；50mltimes;5； 50mltimes;6；50mltimes;7；50mltimes;8；50mltimes;9；50mltimes;10； 60ml；60mltimes;2；60mltimes;3；60mltimes;4；60mltimes;5； 60mltimes;6；60mltimes;7；60mltimes;8；60mltimes;9；60mltimes;10； 70ml；70mltimes;2；70mltimes;3；70mltimes;4；70mltimes;5； 70mltimes;6；70mltimes;7；70mltimes;8；70mltimes;9；70mltimes;10； 80ml；80mltimes;2；80mltimes;3；80mltimes;4；80mltimes;5； 80mltimes;6；80mltimes;7；80mltimes;8；80mltimes;9；80mltimes;10； 90ml；90mltimes;2；90mltimes;3；90mltimes;4；90mltimes;5； 90mltimes;6；90mltimes;7；90mltimes;8；90mltimes;9；90mltimes;10； 100ml；100mltimes;2；100mltimes;3；100mltimes;4；100mltimes;5； 100mltimes;6；100mltimes;7；100mltimes;8；100mltimes;9；100mltimes;10。
Approval department: Beijing Municipal Drug Administration
北京市药品监督管理局

Registration information

Registration number: 京械注准20152400777
Approval date: March 20, 2020
Expiry date: March 19, 2025

Registrant

Name: Beijing Beijian Xinchuangyuan Biotechnology Co., Ltd.
北京北检·新创源生物技术有限公司
Province/Region: Beijing
北京
Address: 1-5-1, 1st to 2nd floor, Building 1, No. 18 Keyuan Road, Daxing District Industrial Development Zone, Beijing
北京市大兴区工业开发区科苑路18号1幢1至2层1-5-1

Production facility

Production address: 北京市大兴区工业开发区科苑路18号1幢1至2层1-5-1

Intended use

English

This product is used for the quantitative determination of total cholesterol content in human serum in vitro.

中文

本产品用于体外定量测定人血清中总胆固醇的含量。

Structure and composition

English

Buffer ge; 50mmol/L Cholesterase ge; 800U/L cholesterol oxidase ge; 400U/L Peroxidase ge; 1000U/L 4-Aminoantipyrine Ge; 1mmol/L TOOS ge;0.3mol/L

中文

缓冲液 ge;50mmol/L 胆固醇酯酶 ge;800U/L 胆固醇氧化酶 ge;400U/L 过氧化物酶 ge;1000U/L 4-氨基安替比林 ge;1mmol/L TOOS ge;0.3mol/L

Storage conditions and expiration

English

Store at 2~8 °C in the dark, valid for 12 months.

中文

2～8℃避光储存，有效期12个月。

Additional information

Appendix: 产品技术要求、说明书

About this record

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20152400777 and owned by Beijing Beijian Xinchuangyuan Biotechnology Co., Ltd.. The device was approved on March 20, 2020.

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.