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Set - Taiwan Registration 33588d4984c475a9c3f1b2a9bea9ae99

Access comprehensive regulatory information for Set in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 33588d4984c475a9c3f1b2a9bea9ae99 and manufactured by MICROGENICS CORPORATION. The authorized representative in Taiwan is ABBOTT LABORATORIES SERVICES LLC TAIWAN BRANCH (U.S.A.).

This page provides complete technical specifications, regulatory compliance details, 5 companies making similar products including ABBOTT IRELAND DIAGNOSTICS DIVISION, SIEMENS HEALTHCARE DIAGNOSTICS INC., and 5 recent registrations in the same category. 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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33588d4984c475a9c3f1b2a9bea9ae99
Registration Details
Taiwan FDA Registration: 33588d4984c475a9c3f1b2a9bea9ae99
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Device Details

Set
TW: ไบžๅŸนๅคๆŸฏ้นผๆชข้ฉ—่ฉฆๅŠ‘็ต„
Risk Class 2

Registration Details

33588d4984c475a9c3f1b2a9bea9ae99

DHA05603435706

Company Information

Product Details

This product is a homogeneous enzyme immunoassay for the qualitative and/or semi-quantitative detection of benzoylecgonine (Cocaine metabolites) in human urine at threshold concentrations of 150 ng/mL or 300 ng/mL on the Alinity c analyzer.

A Clinical chemistry and clinical toxicology

A.3250 Cocaine and its metabolites test system

QMS/QSD;; ่ผธๅ…ฅ

Dates and Status

Feb 02, 2021

Feb 02, 2026