Taiwan FDA registration a3869b115ba03ae25e217eb659b0160b

Appertonine transaminase (activation) assay set

TW: 亞培天門冬胺酸轉胺酶(活化)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 Feb 22, 2019 – Feb 22, 2029Active
Registration details
Analysis ID
a3869b115ba03ae25e217eb659b0160b
Customs Code
DHA05603218700
Company information
Manufacturer Country
United States;;Germany
Product details
Intended Use
This product can be used to quantify aspartine transaminases in human serum or plasma on the Alinity c analyzer.
Product Type (Level 1)
A Clinical chemistry and clinical toxicology
Product Type (Level 2)
A.1100 天門冬胺酸轉胺酶試驗系統
Import Information
Input;; Contract manufacturing
Dates and status
Registration Date
Feb 22, 2019
Expiry Date
Feb 22, 2029
About this record

Access comprehensive regulatory information for Appertonine transaminase (activation) 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 a3869b115ba03ae25e217eb659b0160b 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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