Taiwan FDA registration e8e437ec58ffce9a1f6697a76050fefe

Kefu Alc glycosylated heme test system

TW: 科福Alc醣化血紅素測試系統

Taiwan·Risk Class 2·INFOPIA CO., LTD.·Registered Jul 20, 2012 – Jul 20, 2017Cancelled

Registration details

Analysis ID: e8e437ec58ffce9a1f6697a76050fefe
Customs Code: DHA00602381009

Company information

Manufacturer: INFOPIA CO., LTD.
Manufacturer Country: Korea, Republic of
Authorized Representative: BIOFIRST CORPORATION

Product details

Intended Use: This test system detects hemoglobin Alc (HbAlc%) concentrations in microvascular or venous whole blood as a means of monitoring the medium and long-term mean blood glucose in diabetic patients. Boron affinity analysis is used to separate the glycated hemoglobin from the unglycated site.
Product Type (Level 1): B Hematology, pathology, and genetics
Product Type (Level 2): B.7470 Analysis of glycosylated hemoglobin
Import Information: import

Dates and status

Registration Date: Jul 20, 2012
Expiry Date: Jul 20, 2017
Cancellation Date: Dec 13, 2019

Cancellation information

Status: Logged out
Reason: 許可證已逾有效期

About this record

Access comprehensive regulatory information for Kefu Alc glycosylated heme test system in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number e8e437ec58ffce9a1f6697a76050fefe and manufactured by INFOPIA CO., LTD.. The authorized representative in Taiwan is BIOFIRST CORPORATION.

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