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β-Hydroxybutyrate Assay Kit (β-Hydroxybutyrate Dehydrogenase Method) - NMPA Registration 鲁械注准20242401023

Access comprehensive regulatory information for β-Hydroxybutyrate Assay Kit (β-Hydroxybutyrate Dehydrogenase 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 鲁械注准20242401023 and owned by Qingdao Hightop Biotech Co., Ltd.. The device was approved on November 19, 2024.

This page provides complete registration details including registrant information, province location (Shandong), 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.

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NMPA Official Data
Class II
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)
NMPA Registration Number: 鲁械注准20242401023
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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。

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
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