Taiwan FDA registration 9347f1d49e09d077ed735b732e8ddf67

Abbott designer creatine kinase MB isoenzyme test kit

TW: 亞培設計師肌酸激酶之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 May 02, 2024 – Nov 30, 2025Expired
Registration details
Analysis ID
9347f1d49e09d077ed735b732e8ddf67
Customs Code
DHA00601513004
Company information
Manufacturer Country
Ireland;;United States
Product details
Intended Use
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.
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
import
Dates and status
Registration Date
May 02, 2024
Expiry Date
Nov 30, 2025
About this record

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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