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Apex Designer Aminomethylfolate Test Group - Taiwan Registration 260a141bba66210bd2841303947768bb

Access comprehensive regulatory information for Apex Designer Aminomethylfolate Test Group in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 260a141bba66210bd2841303947768bb 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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260a141bba66210bd2841303947768bb
Registration Details
Taiwan FDA Registration: 260a141bba66210bd2841303947768bb
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Device Details

Apex Designer Aminomethylfolate Test Group
TW: ไบžๅŸน่จญ่จˆๅธซ่ƒบๅŸบ็”ฒๅŸบ่‘‰้…ธๆชข้ฉ—่ฉฆๅŠ‘็ต„
Risk Class 2

Registration Details

260a141bba66210bd2841303947768bb

DHA05602753806

Company Information

Product Details

Performance (discretionary) changed to: This product is used to quantitatively detect aminomethylfolate (methotrexate) in human serum and plasma by chemical cold light particle immunoassay (CMIA) on the ARCHITECT i system. The measurements obtained are used to monitor aminomethylfolate concentrations to ensure appropriate treatment.

A Clinical chemistry and clinical toxicology

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

Input;; Contract manufacturing

Dates and Status

Jul 29, 2015

Jul 29, 2025