Eu Ivdd Eu Ivd General On The Market ๐Ÿ‡จ๐Ÿ‡ณ China

TROPONIN I/T - RT & POC

Ameritech Diagnostic Reagent (Jiaxing) Co., Ltd. ยท ๐Ÿ‡จ๐Ÿ‡ณ China
Devices (same UDI-DI)
1
Certificates
0
Countries
13
Notified Bodies
0

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

๐Ÿ‡จ๐Ÿ‡ฟ Czechia ๐Ÿ‡ฉ๐Ÿ‡ช Germany ๐Ÿ‡ฌ๐Ÿ‡ท Greece ๐Ÿ‡ช๐Ÿ‡ธ Spain ๐Ÿ‡ซ๐Ÿ‡ฎ Finland ๐Ÿ‡ซ๐Ÿ‡ท France ๐Ÿ‡ฎ๐Ÿ‡ธ Iceland ๐Ÿ‡ฎ๐Ÿ‡น Italy ๐Ÿ‡ฑ๐Ÿ‡น Lithuania ๐Ÿ‡ฑ๐Ÿ‡ป Latvia ๐Ÿ‡ณ๐Ÿ‡ฑ Netherlands ๐Ÿ‡ต๐Ÿ‡ฑ Poland ๐Ÿ‡ท๐Ÿ‡ด Romania

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