Apestin A1c test set - Taiwan Registration 8df8012f1348b94f2489ebcf3aa82b65
Access comprehensive regulatory information for Apestin A1c test set in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 8df8012f1348b94f2489ebcf3aa82b65 and manufactured by ABBOTT GMBH;; SEKISUI DIAGNOSTICS P.E.I. INC.. The authorized representative in Taiwan is ABBOTT LABORATORIES SERVICES LLC TAIWAN BRANCH (U.S.A.).
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Device Details
Registration Details
8df8012f1348b94f2489ebcf3aa82b65
DHA05603243707
Product Details
This product is used to quantitatively detect the percentage of heme A1c (NGSP) or HbA1c fragment mmol/mol (IFCC) in human whole blood and hemolytic products in vitro in clinical laboratories on the Alinity c analyzer.
B Hematology, pathology, and genetics
B.7470 Analysis of glycosylated hemoglobin
Contract manufacturing;; input
Dates and Status
May 24, 2019
May 24, 2029

