Taiwan FDA registration 1595a4a43b1579ec04b87aabc74e0f30

Abbott second-generation creatinine assay set

TW: 亞培第二代肌酸酐檢驗試劑組
Taiwan flagTaiwan·Risk Class 2·ABBOTT IRELAND DIAGNOSTICS DIVISION·Registered Sep 30, 2022 – Sep 30, 2027Active
Registration details
Analysis ID
1595a4a43b1579ec04b87aabc74e0f30
Customs Code
DHA05603585807
Company information
Manufacturer Country
Ireland
Product details
Intended Use
This product is used to quantify creatinine in human serum, plasma or urine on the Alinity c System.
Product Type (Level 1)
A Clinical chemistry and clinical toxicology
Product Type (Level 2)
A.1225 肌氨酸酐試驗系統(Creatininetestsystem)
Import Information
QMS/QSD;; 輸入
Dates and status
Registration Date
Sep 30, 2022
Expiry Date
Sep 30, 2027
About this record

Access comprehensive regulatory information for Abbott second-generation creatinine 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 1595a4a43b1579ec04b87aabc74e0f30 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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