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Human heart fatty acid binding protein assay kit (immunoturbidimetric method) - NMPA Registration 皖械注准20172400078

Access comprehensive regulatory information for Human heart fatty acid binding protein assay kit (immunoturbidimetric 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 皖械注准20172400078 and owned by Anhui Daqian Bio-Engineering Limited Company. The device was approved on January 17, 2022.

This page provides complete registration details including registrant information, province location (Anhui), 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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Class II
皖械注准20172400078
Human heart fatty acid binding protein assay kit (immunoturbidimetric method)
人体心脏脂肪酸结合蛋白测定试剂盒(免疫比浊法)
NMPA Registration Number: 皖械注准20172400078
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DJ Fang

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Intended Use
English

It is used for the quantitative determination of the content of human heart fatty acid-binding protein (H-FABP) in human serum in vitro.

中文

用于体外定量测定人血清中人体心脏脂肪酸结合蛋白(H-FABP)的含量。

Device Classification
Device Class
Class II
Model Specifications
R1:1×20ml R2:1×5mlR1:1×32ml R2:1×8mlR1:1×40ml R2:1×10mlR1:1×48ml R2:1×12mlR1:1×40ml R2:2×5mlR1:2×30ml R2:1×15mlR1:1×60ml R2:1×15mlR1:2×40ml R2:1×20mlR1:4×20ml R2:2×10mlR1:2×60ml R2:1×30mlR1:2×60ml R2:2×15mlR1:3×40ml R2:1×30mlR1:4×40ml R2:2×20mlR1:4×50ml R2:2×25mlR1:4×60ml R2:4×15mlR1:4×60ml R2:2×30mlR1:12×60ml R2:3×60mlR1:1×80ml R2:1×7 20mlR1:2×80ml R2:2×20mlR1:3×80ml R2:3×20mlR1:4×80ml R2:4×20mlR1:1×800ml R2:1×200mlR1:1×4000mlR2:1×1000mlR1:5×16ml R2: 5×4ml(300测试) R1:10×16ml R2:10×4ml(600测试)
R1:1×20ml R2:1×5mlR1:1×32ml R2:1×8mlR1:1×40ml R2:1×10mlR1:1×48ml R2:1×12mlR1:1×40ml R2:2×5mlR1:2×30ml R2:1×15mlR1:1×60ml R2:1×15mlR1:2×40ml R2:1×20mlR1:4×20ml R2:2×10mlR1:2×60ml R2:1×30mlR1:2×60ml R2:2×15mlR1:3×40ml R2:1×30mlR1:4×40ml R2:2×20mlR1:4×50ml R2:2×25mlR1:4×60ml R2:4×15mlR1:4×60ml R2:2×30mlR1:12×60ml R2:3×60mlR1:1×80ml R2:1×20mlR1:2×80ml R2:2×20mlR1:3×80ml R2:3×20mlR1:4×80ml R2:4×20mlR1:1×800ml R2:1×200mlR1:1×4000mlR2:1×1000mlR1:5×16ml R2:5×4ml(300测试) R1:10×16ml R2:10×4ml(600测试)
Approval Department
Anhui Provincial Drug Administration
安徽省药品监督管理局
Registration Information
Registration Number
皖械注准20172400078
Approval Date
January 17, 2022
Expiry Date
January 16, 2027
Registrant
Name
Anhui Daqian Bio-Engineering Limited Company
安徽大千生物工程有限公司
Province/Region
Anhui
安徽
Address
Hefei Economic Development District Taohua Industrial Park prosperous Avenue Industrial Investment Liheng Industrial Plaza B12C
合肥市经开区桃花工业园繁华大道工投·立恒工业广场B12C
Production Facility
Production Address
合肥市经开区桃花工业园繁华大道工投·立恒工业广场B12C
Structure and Composition
English

R1: buffer, polyethylene glycol R2: buffer, human heart fatty acid binding protein antibody latex particle calibration solution, quality control: human heart fatty acid binding protein (optional)

中文

R1:缓冲液、聚乙二醇R2:缓冲液、人体心脏脂肪酸结合蛋白抗体乳胶颗粒校准液、质控品:人体心脏脂肪酸结合蛋白(可选)

Storage Conditions and Expiration
English

Store in 2°C~8°C in the dark.

中文

于2℃~8℃避光密封保存。