Taiwan FDA registration 1da21892a10cf58c3c3c0c7655ce1270

MB isoenzyme test group for Api creatine kinase

TW: 亞培肌酸激酶之MB同功酶檢驗試劑組
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 Apr 08, 2020 – Apr 08, 2030Active
Registration details
Analysis ID
1da21892a10cf58c3c3c0c7655ce1270
Customs Code
DHA05603346708
Company information
Manufacturer Country
Ireland;;United States
Product details
Intended Use
This product is used to quantitatively detect the MB isoenzyme (CK-MB) of creatine kinase in human serum and plasma by chemical cold light particle immunoassay (CMIA) on the Alinity i analyzer.
Product Type (Level 1)
A Clinical chemistry and clinical toxicology
Product Type (Level 2)
A.1215 Creatine phosphokinase/creatine kinase or isoenzyme testing system
Import Information
Input;; Contract manufacturing
Dates and status
Registration Date
Apr 08, 2020
Expiry Date
Apr 08, 2030
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About this record

Access comprehensive regulatory information for MB isoenzyme test group for Api creatine kinase in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 1da21892a10cf58c3c3c0c7655ce1270 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.).

This page provides complete technical specifications, regulatory compliance details, 1 companies making similar products including SENTINEL CH. S.p.A., and 1 recent registrations in the same category. Pure Global AI offers free access to 89,000+ Taiwan medical device registrations, helping global MedTech companies navigate Taiwan FDA regulations, identify competitors, and discover partnership opportunities efficiently.

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