Taiwan FDA registration a9cb1275f5044b29215d05233fea8c2d

Api creatine kinase assay set

TW: 亞培肌酸激酶檢驗試劑組
Taiwan flagTaiwan·Risk Class 2·FISHER DIAGNOSTICS, A DIVISION OF FISHER SCIENTIFIC COMPANY, LLC, A PART OF THERMO FISHER SCIENTIFIC INC.;; ABBOTT GMBH·Registered Dec 14, 2018 – Dec 14, 2028Active
Registration details
Analysis ID
a9cb1275f5044b29215d05233fea8c2d
Customs Code
DHA05603197300
Company information
Manufacturer Country
United States;;Germany
Product details
Intended Use
This product is paired with the Alinity c Analyzer to quantify creatine kinase in human serum or plasma.
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
Contract manufacturing;; input
Dates and status
Registration Date
Dec 14, 2018
Expiry Date
Dec 14, 2028
About this record

Access comprehensive regulatory information for Api creatine kinase assay set in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number a9cb1275f5044b29215d05233fea8c2d and manufactured by FISHER DIAGNOSTICS, A DIVISION OF FISHER SCIENTIFIC COMPANY, LLC, A PART OF THERMO FISHER SCIENTIFIC INC.;; ABBOTT GMBH. The authorized representative in Taiwan is ABBOTT LABORATORIES SERVICES LLC TAIWAN BRANCH (U.S.A.).

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