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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.

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1da21892a10cf58c3c3c0c7655ce1270
Registration Details
Taiwan FDA Registration: 1da21892a10cf58c3c3c0c7655ce1270
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Device Details

MB isoenzyme test group for Api creatine kinase
TW: ไบžๅŸน่‚Œ้…ธๆฟ€้…ถไน‹MBๅŒๅŠŸ้…ถๆชข้ฉ—่ฉฆๅŠ‘็ต„
Risk Class 2

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

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