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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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8df8012f1348b94f2489ebcf3aa82b65
Registration Details
Taiwan FDA Registration: 8df8012f1348b94f2489ebcf3aa82b65
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Device Details

Apestin A1c test set
TW: ไบžๅŸน่ก€็ด…็ด A1cๆชข้ฉ—่ฉฆๅŠ‘็ต„
Risk Class 2

Registration Details

8df8012f1348b94f2489ebcf3aa82b65

DHA05603243707

Company Information

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