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Calibration solution and quality control solution of Apex thyronine uptake test set - Taiwan Registration 137954599cf252ac1b83bb906840e874

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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137954599cf252ac1b83bb906840e874
Registration Details
Taiwan FDA Registration: 137954599cf252ac1b83bb906840e874
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Device Details

Calibration solution and quality control solution of Apex thyronine uptake test set
TW: ไบžๅŸน็”ฒ็‹€่…บๆฐจ้…ธๆ”ๅ–็އๆชข้ฉ—่ฉฆๅŠ‘็ต„ไน‹ๆ กๆญฃๆถฒๅŠๅ“็ฎกๆถฒ
Risk Class 2

Registration Details

137954599cf252ac1b83bb906840e874

DHA05603173306

Product Details

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.

A Clinical chemistry and clinical toxicology

A.1660 Quality control materials (analytical and non-analytical); A.1150 calibration

Input;; Contract manufacturing

Dates and Status

Oct 15, 2018

Oct 15, 2028