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Apex galactoglutinin-3 assay set - Taiwan Registration c206f4751fd1a5c02d4c1062b073690f

Access comprehensive regulatory information for Apex galactoglutinin-3 assay set in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number c206f4751fd1a5c02d4c1062b073690f 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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c206f4751fd1a5c02d4c1062b073690f
Registration Details
Taiwan FDA Registration: c206f4751fd1a5c02d4c1062b073690f
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Device Details

Apex galactoglutinin-3 assay set
TW: ไบžๅŸนๅŠไนณ้†ฃๅ‡้›†็ด -3ๆชข้ฉ—่ฉฆๅŠ‘็ต„
Risk Class 2

Registration Details

c206f4751fd1a5c02d4c1062b073690f

DHA05603351404

Company Information

Product Details

This product is used to quantitatively detect galactoglutinin-3 (galectin-3) in human serum and EDTA plasma by chemical cold light particle immunoassay (CMIA) on the Alinity i analyzer.

A Clinical chemistry and clinical toxicology

A.1660 Grade Material (Analysis Material Non-Analysis);; A.1117 Type B diuretic ้ˆ‰่‚ฝ่ฉฆ้ฉ—็ณป็ตฑ;; A.1150 Calibrated Products

Input;; Contract manufacturing

Dates and Status

Jul 24, 2020

Jul 24, 2025