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Abbott Designer Thyroglobulin Test Set - Taiwan Registration c5615fdb3c4f3ba02250f196769d2959

Access comprehensive regulatory information for Abbott Designer Thyroglobulin 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 c5615fdb3c4f3ba02250f196769d2959 and manufactured by FUJIREBIO DIAGNOSTICS, INC.;; ABBOTT GMBH. The authorized representative in Taiwan is ABBOTT LABORATORIES SERVICES LLC TAIWAN BRANCH (U.S.A.).

This page provides complete technical specifications, regulatory compliance details. Pure Global AI offers free access to 89,000+ Taiwan medical device registrations, helping global MedTech companies navigate Taiwan FDA regulations, identify competitors, and discover partnership opportunities efficiently.

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c5615fdb3c4f3ba02250f196769d2959
Registration Details
Taiwan FDA Registration: c5615fdb3c4f3ba02250f196769d2959
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Device Details

Abbott Designer Thyroglobulin Test Set
TW: ไบžๅŸน่จญ่จˆๅธซ็”ฒ็‹€่…บ็ƒ่›‹็™ฝๆชข้ฉ—่ฉฆๅŠ‘็ต„
Risk Class 2

Registration Details

c5615fdb3c4f3ba02250f196769d2959

DHA05603246400

Company Information

Product Details

This product is equipped with the ARCHITECT i system to quantitatively detect thyroglobulin in human serum and plasma using chemical cold light particle immunoassay (CMIA).

A Clinical Chemistry and Clinical Toxicology;; C Immunology and Microbiology

C.6010 Mass phase antigen immunoassay system;; A.1660 Grade Material (Analysis Material Non-Analysis);; A.1150 Calibrated Products

ๅง”่จ—่ฃฝ้€ ;; ่ผธๅ…ฅ;; QMS/QSD

Dates and Status

Jul 08, 2019

Jul 08, 2029