Eu Ivdr Eu Ivd Class B On The Market ๐Ÿ‡ซ๐Ÿ‡ฎ Finland

LDH (IFCC)

Thermo Fisher Scientific Oy ยท ๐Ÿ‡ซ๐Ÿ‡ฎ Finland
Devices (same UDI-DI)
1
Certificates
0
Countries
28
Notified Bodies
0

Basic Information

Primary DI
16438153004384
Basic UDI-DI Code
6438153BU00180BW
Reference
981906
Device Types
None provided
Regulation
Eu Ivdr
Classification
Eu Ivd Class B
Status
On The Market

Additional Description

INTENDED PURPOSE / INTENDED USE For in vitro diagnostic use in the quantitative determination of LDH (L-Lactate: NAD oxidoreductase EC 1.1.1.27) activity in human serum and plasma with the automated procedures of Thermo Scientificโ„ข Indikoโ„ข and Konelabโ„ข analyzers. The LDH (IFCC) test is indicated to be used in conjunction with clinical evaluation for aid to diagnosis and monitoring of variety of diseases, including hematological and oncological diseases, such as hemolytic anemia and leukemia, in patients. Furthermore, the LDH (IFCC) test is indicated to be used for assessing the degree of cell destruction in diseases of liver, cardiac- and skeletal muscles, kidney and lungs, in patients.

CND Nomenclature Codes

Code Description
W01010119 LACTATE DEHYDROGENASE L ( LDH - L --> P )

Available In Countries

๐Ÿ‡ฆ๐Ÿ‡น Austria ๐Ÿ‡ง๐Ÿ‡ช Belgium ๐Ÿ‡ง๐Ÿ‡ฌ Bulgaria ๐Ÿ‡จ๐Ÿ‡พ Cyprus ๐Ÿ‡จ๐Ÿ‡ฟ Czechia ๐Ÿ‡ฉ๐Ÿ‡ช Germany ๐Ÿ‡ฉ๐Ÿ‡ฐ Denmark ๐Ÿ‡ช๐Ÿ‡ช Estonia ๐Ÿ‡ฌ๐Ÿ‡ท Greece ๐Ÿ‡ช๐Ÿ‡ธ Spain ๐Ÿ‡ซ๐Ÿ‡ฎ Finland ๐Ÿ‡ซ๐Ÿ‡ท France ๐Ÿ‡ญ๐Ÿ‡ท Croatia ๐Ÿ‡ญ๐Ÿ‡บ Hungary ๐Ÿ‡ฎ๐Ÿ‡ช Ireland ๐Ÿ‡ฎ๐Ÿ‡น Italy ๐Ÿ‡ฑ๐Ÿ‡ฎ Liechtenstein ๐Ÿ‡ฑ๐Ÿ‡น Lithuania ๐Ÿ‡ฑ๐Ÿ‡บ Luxembourg ๐Ÿ‡ฑ๐Ÿ‡ป Latvia ๐Ÿ‡ฒ๐Ÿ‡น Malta ๐Ÿ‡ต๐Ÿ‡ฑ Poland ๐Ÿ‡ต๐Ÿ‡น Portugal ๐Ÿ‡ท๐Ÿ‡ด Romania ๐Ÿ‡ธ๐Ÿ‡ช Sweden ๐Ÿ‡ธ๐Ÿ‡ฎ Slovenia ๐Ÿ‡ธ๐Ÿ‡ฐ Slovakia ๐Ÿ‡น๐Ÿ‡ท Tรผrkiye

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