Calibration solution and quality control solution of Apex thyroid peroxidase antibody test kit - Taiwan Registration 388b2d5c8d76b5e26a2a6c927ef0fd4d
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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Device Details
Registration Details
388b2d5c8d76b5e26a2a6c927ef0fd4d
DHA05603197109
Product Details
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.
A Clinical chemistry and clinical toxicology
A.1660 Quality control materials (analytical and non-analytical); A.1150 calibration
Input;; Contract manufacturing
Dates and Status
Dec 12, 2018
Dec 12, 2028