Eu Ivdd Eu Ivd General On The Market 🇰🇷 South Korea

FREND Troponin I

NanoEntek, Inc. · 🇰🇷 South Korea
Devices (same UDI-DI)
1
Certificates
0
Countries
5
Notified Bodies
0

Basic Information

Primary DI
08809317540092
Basic UDI-DI Code
B-08809317540092
Reference
FRTI 025
Device Types
Single use
Regulation
Eu Ivdd
Classification
Eu Ivd General
Status
On The Market
Manufacturer
NanoEntek, Inc.

Additional Description

The FREND Troponin I test is a fluorescent nanoparticle immunoassay designed for in vitro quantitative measurement of troponin I(TnI) in human plasma samples using EDTA as the anticoagulant. The FREND Troponin I microfluidic flow cartridge is designed for use in the FREND System to aid in the diagnosis and assessment of the severity of myocardial infarction.

CND Nomenclature Codes

Code Description
W01021306 TROPONIN I/T

Available In Countries

🇩🇪 Germany 🇪🇸 Spain 🇮🇹 Italy 🇱🇹 Lithuania 🇷🇴 Romania

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