Calibration solution and quality control solution of Apex thyronine uptake test set
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 Oct 15, 2018 – Oct 15, 2028Active- Analysis ID
- 137954599cf252ac1b83bb906840e874
- Customs Code
- DHA05603173306
- Manufacturer Country
- Ireland;;United States
- Authorized Representative
- ABBOTT LABORATORIES SERVICES LLC TAIWAN BRANCH (U.S.A.)
- Intended Use
- Calibration Solution: This product is used to correct the Alinity i analyzer to quantitatively test the total binding capacity of human serum or plasma to the thyroid hormone tetraiodothyroxine (T4). Quality Control Fluid: This product is used to verify the accuracy and precision of the Alinity i analyzer, which can quantitatively test the total binding force of the thyroid hormone tetraiodothyroxine (T4) in human serum or 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
- Registration Date
- Oct 15, 2018
- Expiry Date
- Oct 15, 2028
Access comprehensive regulatory information for Calibration solution and quality control solution of Apex thyronine uptake 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 137954599cf252ac1b83bb906840e874 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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