Taiwan FDA registration 1085865b4adec2c68d0864800cf2325a

Abbott designs a thyroglobulin antibody test set

TW: 亞培設計甲狀腺球蛋白抗體檢驗試劑組
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 Jun 22, 2007 – Jun 22, 2027Active
Registration details
Analysis ID
1085865b4adec2c68d0864800cf2325a
Customs Code
DHA00601828509
Company information
Manufacturer Country
Ireland;;United States
Product details
Intended Use
Efficacy (discretionary) changed to: This product is used to quantitatively detect thyroglobulin autoantibodies ́ anti-Tg in human serum and plasma by chemical cold light particle 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
Input;; Contract manufacturing
Dates and status
Registration Date
Jun 22, 2007
Expiry Date
Jun 22, 2027
About this record

Access comprehensive regulatory information for Abbott designs a thyroglobulin antibody test set in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 1085865b4adec2c68d0864800cf2325a 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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