京械注准20232400385

5'-Nucleotidase (5'-NT) Test Kit (Peroxidase Method)

5'-核苷酸酶（5'-NT）测定试剂盒(过氧化物酶法)

Beijing Leadman Biochemistry Co., Ltd.·Class II·NMPA·Approved June 20, 2023

Device classification

Device class: Class II
Model specifications: Reagent 1 (R1): 4times; 60mL, Reagent 2(R2): 4times; 20mL; Reagent 1 (R1): 5times; 60mL, Reagent 2(R2): 5times; 20mL; Reagent 1 (R1): 3times; 60mL, Reagent 2(R2): 1times; 60mL; Reagent 1(R1): 2times; 60mL, Reagent 2(R2): 2times; 20mL; Reagent 1 (R1): 1times; 60mL, Reagent 2(R2): 1times; 20mL; Reagent 1 (R1): 5times; 60mL, Reagent 2(R2): 5times; 15mL; Reagent 1 (R1): 5times; 60mL, Reagent 2(R2): 5times; 12mL; Reagent 1 (R1): 2times; 45mL, Reagent 2(R2): 2times; 15mL; Reagent 1(R1): 1times; 18mL, Reagent 2(R2): 1times; 6mL; Reagent 1 (R1): 2times; 75mL, Reagent 2(R2): 2times; 25mL; Reagent 1 (R1): 4times; 75mL, Reagent 2(R2): 4times; 25mL; Reagent 1 (R1): 2times; 61mL, Reagent 2(R2): 2times; 21mL; Reagent 1 (R1): 5times; 61mL, Reagent 2(R2): 5times; 21mL; 272 test/cassette: (Reagent 1(R1): 1times; 66mL, Reagent 2(R2): 1times; 22mL); 680 test/cassette: (Reagent 1(R1): 2times; 60mL, Reagent 2(R2): 2times; 20mL); 1020 test/cassette: (Reagent 1 (R1): 3times; 60mL, Reagent 2(R2): 3times; 20mL). Calibrators (optional): 1times, 1mL, 1times, 2mL, 1times, 5mL. Quality control (optional): 1times, 1mL, 1times, 2mL, 1times, 5mL.
试剂1（R1）：4times;60mL、试剂2（R2）：4times;20mL；试剂1（R1）：5times;60mL、试剂2（R2）：5times;20mL；试剂1（R1）：3times;60mL、试剂2（R2）：1times;60mL；试剂1（R1）：2times;60mL、试剂2（R2）：2times;20mL；试剂1（R1）：1times;60mL、试剂2（R2）：1times;20mL；试剂1（R1）：5times;60mL、试剂2（R2）：5times;15mL；试剂1（R1）：5times;60mL、试剂2（R2）：5times;12mL；试剂1（R1）：2times;45mL、试剂2（R2）：2times;15mL；试剂1（R1）：1times;18mL、试剂2（R2）：1times;6mL；试剂1（R1）：2times;75mL、试剂2（R2）：2times;25mL；试剂1（R1）：4times;75mL、试剂2（R2）：4times;25mL；试剂1（R1）：2times;61mL、试剂2（R2）：2times;21mL；试剂1（R1）：5times;61mL、试剂2（R2）：5times;21mL； 272测试/盒：（试剂1（R1）：1times;66mL、试剂2（R2）：1times;22mL）； 680测试/盒：（试剂1（R1）：2times;60mL、试剂2（R2）：2times;20mL）； 1020测试/盒：（试剂1（R1）：3times;60mL、试剂2（R2）：3times;20mL）。校准品（选配）：1times;1mL、1times;2mL 、1times;5mL。质控品（选配）：1times;1mL、1times;2mL 、1times;5mL。
Approval department: Beijing Municipal Drug Administration
北京市药品监督管理局

Registration information

Registration number: 京械注准20232400385
Approval date: June 20, 2023
Expiry date: June 19, 2028

Registrant

Name: Beijing Leadman Biochemistry Co., Ltd.
北京利德曼生化股份有限公司
Province/Region: Beijing
北京
Address: No. 5 Xinghai Road, Beijing Economic and Technological Development Zone, Beijing
北京市北京经济技术开发区兴海路5号

Production facility

Production address: 北京市北京经济技术开发区兴海路5号1幢2层、6层、B1层、2幢

Intended use

English

This product is used for the quantitative determination of serum 5#39 in vitro; - Nucleotidase activity.

中文

本产品用于体外定量测定血清中5#39;-核苷酸酶的活性。

Additional information

Appendix: 产品技术要求、说明书

About this record

Access comprehensive regulatory information for 5'-Nucleotidase (5'-NT) Test Kit (Peroxidase 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20232400385 and owned by Beijing Leadman Biochemistry Co., Ltd.. The device was approved on June 20, 2023.

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.