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Fructoseamine Test Kit (Nitroblue Tetrazolium Blue Colorimetric Method) - NMPA Registration 皖械注准20172400115

Access comprehensive regulatory information for Fructoseamine Test Kit (Nitroblue Tetrazolium Blue Colorimetric 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20172400115 and owned by Anhui Daqian Bio-Engineering Limited Company. The device was approved on January 28, 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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NMPA Official Data
Class II
皖械注准20172400115
Fructoseamine Test Kit (Nitroblue Tetrazolium Blue Colorimetric Method)
果糖胺测定试剂盒(硝基四氮唑蓝显色法)
NMPA Registration Number: 皖械注准20172400115
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Intended Use
English

It is used for the quantitative detection of fructosamine content in human serum in vitro.

中文

用于体外定量检测人血清中果糖胺的含量。

Device Classification
Device Class
Class II
Model Specifications
单试剂型:R:1×20mlR:1×30mlR:1×40mlR:1×50mlR:1×60mlR:2×40mlR:2×50mlR:2×60mlR:3×40mlR:4×30mlR:3×50mlR:3×60mlR:2×100mlR:5×40mlR:4×60mlR:5×50mlR:3×100mlR:5×60mlR:6×50mlR:6×60mlR:16×60mlR:1×1000mlR:1×5000mlR:5×24ml(360测试) R:10×24ml(720测试) 双试剂型:R1:1×15ml R2:1×5mlR1:1×30ml R2:1×10ml R1:1×45ml R2:1×15ml R1:1×60ml R2:1×20mlR1:2×30ml R2:2×10ml R1:2×45ml R2:1×30mlR1:2×45ml R2:2×15mlR1:3×30ml R2:3×10mlR1:2×60ml R2:1×40ml R1:2×60ml R2:2×20ml R1:3×45ml R2:3×15mlR1:3×50ml R2:1×50ml R1: 3×50ml R2:2×25mlR1:4×45ml R2:2×30ml R1:5×45ml R2:3×25ml R1:4×60ml R2:2×40ml R1:4×60ml R2:4×20mlR1:3×80ml R2:2×40ml R1:12×60ml R2:4×60ml R1:1×750ml R2:1×250ml R1:1×3750ml R2:1×1250ml R1:5×18ml R2:5×6ml(360测试) R1:10×18ml R2:10×6ml(720测试).
单试剂型:R:1×20mlR:1×30mlR:1×40mlR:1×50mlR:1×60mlR:2×40mlR:2×50mlR:2×60mlR:3×40mlR:4×30mlR:3×50mlR:3×60mlR:2×100mlR:5×40mlR:4×60mlR:5×50mlR:3×100mlR:5×60mlR:6×50mlR:6×60mlR:16×60mlR:1×1000mlR:1×5000mlR:5×24ml(360测试) R:10×24ml(720测试) 双试剂型:R1:1×15ml R2:1×5mlR1:1×30ml R2:1×10ml R1:1×45ml R2:1×15ml R1:1×60ml R2:1×20mlR1:2×30ml R2:2×10ml R1:2×45ml R2:1×30mlR1:2×45ml R2:2×15mlR1:3×30ml R2:3×10mlR1:2×60ml R2:1×40ml R1:2×60ml R2:2×20ml R1:3×45ml R2:3×15mlR1:3×50ml R2:1×50ml R1:3×50ml R2:2×25mlR1:4×45ml R2:2×30ml R1:5×45ml R2:3×25ml R1:4×60ml R2:2×40ml R1:4×60ml R2:4×20mlR1:3×80ml R2:2×40ml R1:12×60ml R2:4×60ml R1:1×750ml R2:1×250ml R1:1×3750ml R2:1×1250ml R1:5×18ml R2:5×6ml(360测试) R1:10×18ml R2:10×6ml(720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20172400115
Approval Date
January 28, 2022
Expiry Date
September 06, 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

The main components of the single-reagent type kit: sodium bicarbonate buffer, nitrotetrazolium blue; Calibrating solution. Main components of the double reagent type kit: reagent R1: carbonate buffer; Reagent R2: nitrotetrazolium blue; Calibrating solution.

中文

单试剂型试剂盒主要成分:碳酸氢钠缓冲液、硝基四氮唑蓝;校准液。双试剂型试剂盒主要成分:试剂R1:碳酸盐缓冲液;试剂R2:硝基四氮唑蓝;校准液。

Storage Conditions and Expiration
English

Store in 2 °C ~ 8 °C dark seal, valid for one year.

中文

于2℃~8℃避光密封保存,有效期为一年。