MB isoenzyme test group for Api creatine kinase - Taiwan Registration 1da21892a10cf58c3c3c0c7655ce1270
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.
Device Details
Registration Details
1da21892a10cf58c3c3c0c7655ce1270
DHA05603346708
Product Details
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.
A Clinical chemistry and clinical toxicology
A.1215 Creatine phosphokinase/creatine kinase or isoenzyme testing system
Input;; Contract manufacturing
Dates and Status
Apr 08, 2020
Apr 08, 2030

