Taiwan FDA registration a59ec9affa086ca997168f996ba57805

Abbott second-generation alkaline phosphatase assay set

TW: 亞培第二代鹼性磷酸酶檢驗試劑組

Taiwan·Risk Class 2·ABBOTT IRELAND DIAGNOSTICS DIVISION·Registered Nov 09, 2022 – Nov 09, 2027Active

Registration details

Analysis ID: a59ec9affa086ca997168f996ba57805
Customs Code: DHA05603588102

Company information

Manufacturer: ABBOTT IRELAND DIAGNOSTICS DIVISION
Manufacturer Country: Ireland
Authorized Representative: ABBOTT LABORATORIES SERVICES LLC TAIWAN BRANCH (U.S.A.)

Product details

Intended Use: This product is used to quantify salty phosphatase (alkaline phosphatase) in human serum or plasma on the Alinity c System.
Product Type (Level 1): A Clinical chemistry and clinical toxicology
Product Type (Level 2): A.1050 Alkaline phosphatase or isoenzyme testing system
Import Information: QMS/QSD;; 輸入

Dates and status

Registration Date: Nov 09, 2022
Expiry Date: Nov 09, 2027

About this record

Access comprehensive regulatory information for Abbott second-generation alkaline phosphatase assay set in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number a59ec9affa086ca997168f996ba57805 and manufactured by ABBOTT IRELAND DIAGNOSTICS DIVISION. The authorized representative in Taiwan is ABBOTT LABORATORIES SERVICES LLC TAIWAN BRANCH (U.S.A.).

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