Taiwan FDA registration d3ad0548966cf295ac70162e8ce734b1

Abbott designer thyroid peroxidase antibody test kit

TW: 亞培設計師甲狀腺過氧化酶抗體檢驗試劑組
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 Jul 10, 2007 – Jul 10, 2027Active
Registration details
Analysis ID
d3ad0548966cf295ac70162e8ce734b1
Customs Code
DHA00601829104
Company information
Manufacturer Country
Ireland;;United States
Product details
Intended Use
This product is used for the quantitative detection of IgG class of thyroid peroxidase autoantibodies (anti-TPO) in human serum and plasma by chemical cold photoparticle immunoassay (CMIA) on the ARCHITECT i system.
Product Type (Level 1)
C Immunology and microbiology
Product Type (Level 2)
C.5870 甲狀腺自體抗體免疫試驗系統
Import Information
Contract manufacturing;; input
Dates and status
Registration Date
Jul 10, 2007
Expiry Date
Jul 10, 2027
About this record

Access comprehensive regulatory information for Abbott designer thyroid peroxidase antibody 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 d3ad0548966cf295ac70162e8ce734b1 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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