Taiwan FDA registration 8df8012f1348b94f2489ebcf3aa82b65

Apestin A1c test set

TW: 亞培血紅素A1c檢驗試劑組

Taiwan·Risk Class 2·ABBOTT GMBH;; SEKISUI DIAGNOSTICS P.E.I. INC.·Registered May 24, 2019 – May 24, 2029Active

Registration details

Analysis ID: 8df8012f1348b94f2489ebcf3aa82b65
Customs Code: DHA05603243707

Company information

Manufacturer: ABBOTT GMBH;; SEKISUI DIAGNOSTICS P.E.I. INC.
Manufacturer Country: Canada;;Germany
Authorized Representative: ABBOTT LABORATORIES SERVICES LLC TAIWAN BRANCH (U.S.A.)

Product details

Intended Use: 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.
Product Type (Level 1): B Hematology, pathology, and genetics
Product Type (Level 2): B.7470 Analysis of glycosylated hemoglobin
Import Information: Contract manufacturing;; input

Dates and status

Registration Date: May 24, 2019
Expiry Date: May 24, 2029

About this record

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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