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Apex thyroglobulin test set - Taiwan Registration a46b58936994ab948908753062fd72d4

Access comprehensive regulatory information for Apex 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 a46b58936994ab948908753062fd72d4 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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a46b58936994ab948908753062fd72d4
Registration Details
Taiwan FDA Registration: a46b58936994ab948908753062fd72d4
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Device Details

Apex thyroglobulin test set
TW: ไบžๅŸน็”ฒ็‹€่…บ็ƒ่›‹็™ฝๆชข้ฉ—่ฉฆๅŠ‘็ต„
Risk Class 2

Registration Details

a46b58936994ab948908753062fd72d4

DHA05603439208

Company Information

Product Details

This product is used to quantitatively detect thyroglobulin in human serum and plasma by chemical cold light particle immunoassay (CMIA) on the Alinity i analyzer. Testing thyroglobulin can be used to help monitor patients after a total thyroidectomy (thyroidectomy).

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

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Dates and Status

Apr 14, 2021

Apr 14, 2026