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QuickProfit Heart 2-in-1 Test Reagent - Taiwan Registration 1057678ae4499ee9a1cacc029863b5bb

Access comprehensive regulatory information for QuickProfit Heart 2-in-1 Test Reagent in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 1057678ae4499ee9a1cacc029863b5bb and manufactured by Quidel Cardiovascular Inc.. The authorized representative in Taiwan is BIO-CHECK LABORATORIES LTD..

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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1057678ae4499ee9a1cacc029863b5bb
Registration Details
Taiwan FDA Registration: 1057678ae4499ee9a1cacc029863b5bb
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Device Details

QuickProfit Heart 2-in-1 Test Reagent
TW: ๅฟซๅพ—ๅˆฉ ๆฃ่€ถๆฟŸ ๅฟƒ่‡ŸไบŒๅˆไธ€ๆชข้ฉ—่ฉฆๅŠ‘
Risk Class 2

Registration Details

1057678ae4499ee9a1cacc029863b5bb

DHA05602840709

Company Information

United States

Product Details

This reagent is used in conjunction with the Alere Triage MeterPro analyzer for immunofluorescence analysis, which can quickly and quantitatively detect the content of troponin I and B-type natriuretic peptide in whole blood and plasma samples treated with EDTA anticoagulation.

A Clinical chemistry and clinical toxicology

A.1117 Type B Natriuretic Peptide Test System;; A.1215 Creatine phosphokinase/creatine kinase or isoenzyme testing system; A.1660 Quality control materials (analytical and non-analytical)

import

Dates and Status

Apr 19, 2016

Apr 19, 2026