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Calibration solution and quality control solution of Apex thyroglobulin antibody test reagent set - Taiwan Registration 42a82ace1e429e22302bc48515bc30ad

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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42a82ace1e429e22302bc48515bc30ad
Registration Details
Taiwan FDA Registration: 42a82ace1e429e22302bc48515bc30ad
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Device Details

Calibration solution and quality control solution of Apex thyroglobulin antibody test reagent set
TW: ไบžๅŸน็”ฒ็‹€่…บ็ƒ่›‹็™ฝๆŠ—้ซ”ๆชข้ฉ—่ฉฆๅŠ‘็ต„ไน‹ๆ กๆญฃๆถฒๅŠๅ“็ฎกๆถฒ
Risk Class 2

Registration Details

42a82ace1e429e22302bc48515bc30ad

DHA05603200201

Product Details

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.

A Clinical chemistry and clinical toxicology

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

Input;; Contract manufacturing

Dates and Status

Jan 03, 2019

Jan 03, 2029