Taiwan FDA registration 3b5fe496f67336c8457182532dd61620

MB isoenzyme test kit for Alepec creatine kinase calibration solution

TW: 亞培肌酸激酶之MB同功酶檢驗試劑組 校正液
Taiwan flagTaiwan·Risk Class 2·FISHER DIAGNOSTICS, A DIVISION OF FISHER SCIENTIFIC COMPANY, LLC, A PART OF THERMO FISHER SCIENTIFIC INC.;; ABBOTT IRELAND DIAGNOSTICS DIVISION·Registered Jan 08, 2020 – Jan 08, 2030Active
Registration details
Analysis ID
3b5fe496f67336c8457182532dd61620
Customs Code
DHA05603312506
Company information
Manufacturer Country
Ireland;;United States
Product details
Intended Use
This product is used to calibrate the Alinity i Analyzer for the quantitative detection of the MB isoenzyme (CK-MB) of creatine kinase in human serum and plasma.
Product Type (Level 1)
A Clinical chemistry and clinical toxicology
Product Type (Level 2)
A.1150 Calibrated Products
Import Information
Input;; Contract manufacturing
Dates and status
Registration Date
Jan 08, 2020
Expiry Date
Jan 08, 2030
About this record

Access comprehensive regulatory information for MB isoenzyme test kit for Alepec creatine kinase calibration solution in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 3b5fe496f67336c8457182532dd61620 and manufactured by FISHER DIAGNOSTICS, A DIVISION OF FISHER SCIENTIFIC COMPANY, LLC, A PART OF THERMO FISHER SCIENTIFIC INC.;; ABBOTT IRELAND DIAGNOSTICS DIVISION. The authorized representative in Taiwan is ABBOTT LABORATORIES SERVICES LLC TAIWAN BRANCH (U.S.A.).

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