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Abbott designer creatine kinase MB isoenzyme test kit - Taiwan Registration 9347f1d49e09d077ed735b732e8ddf67

Access comprehensive regulatory information for Abbott designer creatine kinase MB isoenzyme test kit in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 9347f1d49e09d077ed735b732e8ddf67 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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9347f1d49e09d077ed735b732e8ddf67
Registration Details
Taiwan FDA Registration: 9347f1d49e09d077ed735b732e8ddf67
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Device Details

Abbott designer creatine kinase MB isoenzyme test kit
TW: ไบžๅŸน่จญ่จˆๅธซ่‚Œ้…ธๆฟ€้…ถไน‹MBๅŒๅŠŸ้…ถๆชข้ฉ—่ฉฆๅŠ‘็ต„
Risk Class 2

Registration Details

9347f1d49e09d077ed735b732e8ddf67

DHA00601513004

Product Details

This product is used for the quantitative detection of the MB isoenzyme of creatine kinase in human serum and plasma by chemical cold light microparticle immunoassay (CMIA) on the ARCHITECT i system equipped with the STAT program.

A Clinical chemistry and clinical toxicology

A.1215 Creatine phosphokinase/creatine kinase or isoenzyme testing system

import

Dates and Status

May 02, 2024

Nov 30, 2025