"ARKOLAI" glycosylated hemoglobin analysis system - Taiwan Registration 28cc663a96f1e7e0690b6f821cc84f42
Access comprehensive regulatory information for "ARKOLAI" glycosylated hemoglobin analysis system in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 28cc663a96f1e7e0690b6f821cc84f42 and manufactured by EKF-DIAGNOSTIC GMBH. The authorized representative in Taiwan is MEDTRI CO., LTD..
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Device Details
Product Details
This product is intended to be quantified for in vitro glycoglycated hemoglobin (HbAlc) using whole blood obtained from blood taken from fingertips or from intravenous whole blood samples collected in EDTA test tubes.
B Haematology, pathology and genetics; A Clinical chemistry and clinical toxicology
A.1660 Quality control materials (analytical and non-analytical); B.7470 Analysis of glycosylated hemoglobin
import
Dates and Status
Jun 08, 2018
Jun 08, 2028