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Apeimine methylfolate test group - Taiwan Registration 493b22294697a49a0e4a15bb60fe93d8

Access comprehensive regulatory information for Apeimine methylfolate 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 493b22294697a49a0e4a15bb60fe93d8 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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493b22294697a49a0e4a15bb60fe93d8
Registration Details
Taiwan FDA Registration: 493b22294697a49a0e4a15bb60fe93d8
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Device Details

Apeimine methylfolate test group
TW: ไบžๅŸน่ƒบๅŸบ็”ฒๅŸบ่‘‰้…ธๆชข้ฉ—่ฉฆๅŠ‘็ต„
Risk Class 2

Registration Details

493b22294697a49a0e4a15bb60fe93d8

DHA05603313002

Company Information

Product Details

This product is used to quantitatively detect aminomethylfolate (methotrexate) in human serum and plasma by chemical cold light particle immunoassay (CMIA) on the Alinity i analyzer. 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

Jan 10, 2020

Jan 10, 2030