China NMPA legacy archive 京械注准202324003855'-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 IINMPAApproved June 20, 2023
Static archiveNMPA · legacy registration snapshot
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.
- Approval department
- Beijing Municipal Drug Administration
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。
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
- Province/Region
- Beijing
- Address
- No. 5 Xinghai Road, Beijing Economic and Technological Development Zone, Beijing
北京
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
This static archive preserves historical registration fields and translations for 5'-Nucleotidase (5'-NT) Test Kit (Peroxidase Method), registration 京械注准20232400385. 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.