Eu Ivdd Eu Ivd General On The Market 🇨🇳 China

TROPONIN I/T - RT & POC

Devices (same UDI-DI)
1
Certificates
0
Countries
13
Notified Bodies
0

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Basic Information

Primary DI
06941571822001
Basic UDI-DI Code
B-06941571822001
Reference
R22-112
Device Types
Single use
Regulation
Eu Ivdd
Classification
Eu Ivd General
Status
On The Market

Additional Description

For the rapid qualitative detection of cardiac Troponin I (cTnI) in human whole blood, serum and plasma as an aid in the diagnosis of myocardial infarction. cTnI assay provides a qualitative analytical test result. The qualitative nature of this assay does not provide information about change- either the rise or fall - in the concentration of cTnI with single testing. A quantitative method should be used, if desired, to determine the concentration of cTnI at any given time. Clinical consideration and professional judgment should be applied when interpreting the results cTnI Assay, especially when single testing results are used.

CND Nomenclature Codes

Code Description
W0102160703 TROPONIN I/T - RT & POC

Available In Countries

🇨🇿 Czechia 🇩🇪 Germany 🇬🇷 Greece 🇪🇸 Spain 🇫🇮 Finland 🇫🇷 France 🇮🇸 Iceland 🇮🇹 Italy 🇱🇹 Lithuania 🇱🇻 Latvia 🇳🇱 Netherlands 🇵🇱 Poland 🇷🇴 Romania

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