Taiwan FDA registration d54bc3cd02ace5bee6d176458b40d495

D-100 HbA1c Analytical Cartridge/Calibrator Pack

TW: 醣百適糖化血色素檢測試劑

Taiwan·Risk Class 2·MD·BIO-RAD LABORATORIES INC.·Registered Sep 12, 2016 – Sep 12, 2026Active

Registration details

Analysis ID: d54bc3cd02ace5bee6d176458b40d495
License Form: Ministry of Health Medical Device Import No. 028489
Customs Code: DHA05602848901

Company information

Manufacturer: BIO-RAD LABORATORIES INC.
Manufacturer Country: United States
Authorized Representative: Bio-Rad Laboratories Inc., Taiwan Branch (U.S.A.)

Product details

Intended Use: This product is quantitatively determined by ion exchange high performance liquid chromatography (HPLC) to determine hemoglobin A1c in human whole blood.
Product Type (Level 1): B Hematology and pathology devices
Product Type (Level 2): B7470 Glycosylated heme analysis
Import Information: Imported from abroad

Dates and status

Registration Date: Sep 12, 2016
Expiry Date: Sep 12, 2026

About this record

Access comprehensive regulatory information for D-100 HbA1c Analytical Cartridge/Calibrator Pack in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number d54bc3cd02ace5bee6d176458b40d495 and manufactured by BIO-RAD LABORATORIES INC.. The authorized representative in Taiwan is Bio-Rad Laboratories Inc., Taiwan Branch (U.S.A.).

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