Taiwan FDA registration 42a82ace1e429e22302bc48515bc30ad

Calibration solution and quality control solution of Apex thyroglobulin antibody test reagent set

TW: 亞培甲狀腺球蛋白抗體檢驗試劑組之校正液及品管液
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 Jan 03, 2019 – Jan 03, 2029Active
Registration details
Analysis ID
42a82ace1e429e22302bc48515bc30ad
Customs Code
DHA05603200201
Company information
Manufacturer Country
Ireland;;United States
Product details
Intended Use
Calibration solution: This product is used with Alinity i analyzer for the quantitative detection of IgG thyroglobulin autologous antibody (anti-Tg) correction in human serum and plasma. Quality control solution: This product is used with Alinity i analyzer (reagent, calibration solution and instrument) for the quantitative determination of IgG thyroglobulin autoantibody (anti-Tg) in human serum and plasma.
Product Type (Level 1)
A Clinical chemistry and clinical toxicology
Product Type (Level 2)
A.1660 Quality control materials (analytical and non-analytical); A.1150 calibration
Import Information
Input;; Contract manufacturing
Dates and status
Registration Date
Jan 03, 2019
Expiry Date
Jan 03, 2029
About this record

Access comprehensive regulatory information for Calibration solution and quality control solution of Apex thyroglobulin antibody test reagent set in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 42a82ace1e429e22302bc48515bc30ad 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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