Calibration solution and quality control solution of Apex thyroid peroxidase antibody test kit
Taiwan·Risk Class 2·FISHER DIAGNOSTICS, A DIVISION OF FISHER SCIENTIFIC COMPANY, LLC, A PART OF THERMO FISHER SCIENTIFIC INC.;; ABBOTT IRELAND DIAGNOSTICS DIVISION·Registered Dec 12, 2018 – Dec 12, 2028Active- Analysis ID
- 388b2d5c8d76b5e26a2a6c927ef0fd4d
- Customs Code
- DHA05603197109
- Manufacturer Country
- Ireland;;United States
- Authorized Representative
- ABBOTT LABORATORIES SERVICES LLC TAIWAN BRANCH (U.S.A.)
- Intended Use
- Efficacy (discretionary) changes: 1. Correction solution: This product is used to calibrate the Alinity i analyzer when it is used to quantitatively detect thyroid peroxidase IgG autologous antibody (anti-TPO) in human serum and plasma. 2. Quality control solution: This product is used to quantitatively detect thyroid peroxidase IgG autologous antibody (anti-TPO) in human serum and plasma, evaluate the test precision of the Alinity i analyzer (reagent, calibration solution and instrument) and detect the analysis deviation of the system.
- 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
- Registration Date
- Dec 12, 2018
- Expiry Date
- Dec 12, 2028
Access comprehensive regulatory information for Calibration solution and quality control solution of Apex 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 388b2d5c8d76b5e26a2a6c927ef0fd4d 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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