Taiwan FDA registration fa6c27534608a597857341fb3fb937fd

"Abbott" Efinin glycated hemoglobin test set

TW: "亞培"艾菲寧糖化血色素檢驗試劑組

Taiwan·Risk Class 2·ABBOTT DIAGNOSTICS TECHNOLOGIES AS·Registered Jun 08, 2016 – Jun 08, 2026Expired

Registration details

Analysis ID: fa6c27534608a597857341fb3fb937fd
Customs Code: DHA05602844007

Company information

Manufacturer: ABBOTT DIAGNOSTICS TECHNOLOGIES AS
Manufacturer Country: Norway
Authorized Representative: Abbott Rapid Diagnostics Health Corp.

Product details

Intended Use: This product is used for the quantitative detection of glycated heme (hemoglobin A1c, HbA1c) in human whole blood and is used with the Alere Afinion AS100/Afinion 2 analyzer
Product Type (Level 1): B Haematology, pathology and genetics; A Clinical chemistry and clinical toxicology
Product Type (Level 2): A.1660 Quality control materials (analytical and non-analytical); B.7470 Analysis of glycosylated hemoglobin
Import Information: import

Dates and status

Registration Date: Jun 08, 2016
Expiry Date: Jun 08, 2026

About this record

Access comprehensive regulatory information for "Abbott" Efinin glycated hemoglobin 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 fa6c27534608a597857341fb3fb937fd and manufactured by ABBOTT DIAGNOSTICS TECHNOLOGIES AS. The authorized representative in Taiwan is Abbott Rapid Diagnostics Health Corp..

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