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Speedy Burnsen glycated hemoglobin test agent - Taiwan Registration 478fb18ffece334e81641a3d9c207e40

Access comprehensive regulatory information for Speedy Burnsen glycated hemoglobin test agent in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 478fb18ffece334e81641a3d9c207e40 and manufactured by SD BIOSENSOR, INC.. The authorized representative in Taiwan is CREATIVE LIFE SCIENCE CO., LTD..

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478fb18ffece334e81641a3d9c207e40
Registration Details
Taiwan FDA Registration: 478fb18ffece334e81641a3d9c207e40
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Device Details

Speedy Burnsen glycated hemoglobin test agent
TW: ้€Ÿๅพ—็™พๆฃฎ็ณ–ๅŒ–่ก€่‰ฒ็ด ๆชขๆธฌๆธฌ่ฉฆๅŠ‘
Risk Class 2

Registration Details

478fb18ffece334e81641a3d9c207e40

DHA05603586201

Company Information

Korea, Republic of

Product Details

This product is used to quantitatively measure HbA1c in human venous whole blood. THIS TEST IS INTENDED FOR PROFESSIONAL USE TO MONITOR GLYCEMIC CONTROL IN DIABETIC PATIENTS AND IS INTERPRETED WITH AN APPROPRIATE STANDARD F FLUORESCENCE ANALYZER (MANUFACTURED BY SD BIOSENSOR).

B Hematology, pathology, and genetics

B.7470 Analysis of glycosylated hemoglobin

Input;; QMS/QSD

Dates and Status

Oct 07, 2022

Oct 07, 2027