Taiwan FDA registration 478fb18ffece334e81641a3d9c207e40
Speedy Burnsen glycated hemoglobin test agent
TW: 速得百森糖化血色素檢測測試劑
Taiwan·Risk Class 2·SD BIOSENSOR, INC.·Registered Oct 07, 2022 – Oct 07, 2027ActiveRegistration details
- Analysis ID
- 478fb18ffece334e81641a3d9c207e40
- Customs Code
- DHA05603586201
Company information
- Manufacturer
- SD BIOSENSOR, INC.
- Manufacturer Country
- Korea, Republic of
- Authorized Representative
- CREATIVE LIFE SCIENCE CO., LTD.
Product details
- Intended Use
- 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).
- Product Type (Level 1)
- B Hematology, pathology, and genetics
- Product Type (Level 2)
- B.7470 Analysis of glycosylated hemoglobin
- Import Information
- Input;; QMS/QSD
Dates and status
- Registration Date
- Oct 07, 2022
- Expiry Date
- Oct 07, 2027
About this record
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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