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MB isoenzyme test kit for Alepec creatine kinase calibration solution - Taiwan Registration 3b5fe496f67336c8457182532dd61620

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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3b5fe496f67336c8457182532dd61620
Registration Details
Taiwan FDA Registration: 3b5fe496f67336c8457182532dd61620
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Device Details

MB isoenzyme test kit for Alepec creatine kinase calibration solution
TW: ไบžๅŸน่‚Œ้…ธๆฟ€้…ถไน‹MBๅŒๅŠŸ้…ถๆชข้ฉ—่ฉฆๅŠ‘็ต„ ๆ กๆญฃๆถฒ
Risk Class 2

Registration Details

3b5fe496f67336c8457182532dd61620

DHA05603312506

Product Details

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.

A Clinical chemistry and clinical toxicology

A.1150 Calibrated Products

Input;; Contract manufacturing

Dates and Status

Jan 08, 2020

Jan 08, 2030