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.).
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Device Details
Registration Details
260a141bba66210bd2841303947768bb
DHA05602753806
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

