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Api ethanol assay set - Taiwan Registration 3170f438f2279c8ede0394743fc328f1

Access comprehensive regulatory information for Api ethanol 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 3170f438f2279c8ede0394743fc328f1 and manufactured by B.R.A.H.M.S GmbH;; MICROGENICS CORPORATION. The authorized representative in Taiwan is ABBOTT LABORATORIES SERVICES LLC TAIWAN BRANCH (U.S.A.).

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3170f438f2279c8ede0394743fc328f1
Registration Details
Taiwan FDA Registration: 3170f438f2279c8ede0394743fc328f1
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Device Details

Api ethanol assay set
TW: ไบžๅŸนไน™้†‡ๆชข้ฉ—่ฉฆๅŠ‘็ต„
Risk Class 2

Registration Details

3170f438f2279c8ede0394743fc328f1

DHA05603417704

Company Information

Product Details

This product is used for the quantitative detection of ethanol in human urine, serum or plasma on an Alinity c analyzer.

A Clinical chemistry and clinical toxicology

A.1660 Grade Material (Analysis Material Non-Analysis);; A.1150 Calibrated Products;; A.3040 Sake Essence Trial System

QMS/QSD;; ๅง”่จ—่ฃฝ้€ ;; ่ผธๅ…ฅ

Dates and Status

Dec 18, 2020

Dec 18, 2025