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China NMPA legacy archive 鲁械注准20242401023

β-Hydroxybutyrate Assay Kit (β-Hydroxybutyrate Dehydrogenase Method)

β-羟丁酸测定试剂盒(β-羟丁酸脱氢酶法)
Qingdao Hightop Biotech Co., Ltd.Class IINMPAApproved November 19, 2024
Static archiveNMPA · legacy registration snapshot
Device classification
Device class
Class II
Model specifications
R1:30mL×2 R2:10mL×1;R1:60mL×4 R2:20mL×2; R1:60mL×2 R2:10mL×2;R1:60mL×2 R2:20mL×1; R1:50mL×6 R2:50mL×1;R1:40mL×3 R2:20mL×1; R1:60mL×1 R2:10mL×1;R1:30mL×1 R2:5mL×1; 100测试/盒;200测试/盒;300测试/盒;400测试/盒; 600测试/盒;1200测试/盒.
R1:30mL×2 R2:10mL×1;R1:60mL×4 R2:20mL×2; R1:60mL×2 R2:10mL×2;R1:60mL×2 R2:20mL×1; R1:50mL×6 R2:50mL×1;R1:40mL×3 R2:20mL×1; R1:60mL×1 R2:10mL×1;R1:30mL×1 R2:5mL×1; 100测试/盒;200测试/盒;300测试/盒;400测试/盒; 600测试/盒;1200测试/盒。
Approval department
Shandong Provincial Drug Administration
山东省药品监督管理局
Registration information
Registration number
鲁械注准20242401023
Approval date
November 19, 2024
Expiry date
November 18, 2029
Registrant
Name
Qingdao Hightop Biotech Co., Ltd.
青岛汉唐生物科技有限公司
Province/Region
Shandong
山东
Address
No. 369, Hedong Road, Qingdao High-tech Industrial Development Zone
青岛高新技术产业开发区河东路369号
Production facility
Production address
青岛高新技术产业开发区河东路369号
Intended use
English

It is used for the quantitative determination of β-hydroxybutyric acid content in human serum in vitro.

中文

用于体外定量测定人血清中β-羟丁酸的含量。

Structure and composition
English

试剂R1:三羟甲基氨基甲烷(12.114g/L)、3-羟丁酸脱氢酶(0.15KU/L)、黄递酶(1KU/L); 试剂R2:三羟甲基氨基甲烷(12.114g/L)、氧化型烟酰胺腺嘌呤二核苷酸(1.659g/L)、碘硝基氯化四氮唑蓝(氧化型)(10.114g/L).

中文

试剂R1:三羟甲基氨基甲烷(12.114g/L)、3-羟丁酸脱氢酶(0.15KU/L)、黄递酶(1KU/L); 试剂R2:三羟甲基氨基甲烷(12.114g/L)、氧化型烟酰胺腺嘌呤二核苷酸(1.659g/L)、碘硝基氯化四氮唑蓝(氧化型)(10.114g/L)。

Storage conditions and expiration
English

2 °C ~ 8 °C storage, valid for 12 months.

中文

2℃~8℃保存,有效期12个月。

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 β-Hydroxybutyrate Assay Kit (β-Hydroxybutyrate Dehydrogenase Method), registration 鲁械注准20242401023. 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.