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Kefu Alc glycosylated heme test system - Taiwan Registration e8e437ec58ffce9a1f6697a76050fefe

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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e8e437ec58ffce9a1f6697a76050fefe
Registration Details
Taiwan FDA Registration: e8e437ec58ffce9a1f6697a76050fefe
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Device Details

Kefu Alc glycosylated heme test system
TW: ็ง‘็ฆAlc้†ฃๅŒ–่ก€็ด…็ด ๆธฌ่ฉฆ็ณป็ตฑ
Risk Class 2
Cancelled

Registration Details

e8e437ec58ffce9a1f6697a76050fefe

DHA00602381009

Company Information

Korea, Republic of

Product Details

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.

B Hematology, pathology, and genetics

B.7470 Analysis of glycosylated hemoglobin

import

Dates and Status

Jul 20, 2012

Jul 20, 2017

Dec 13, 2019

Cancellation Information

Logged out

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