Eu Ivdd Eu Ivd General On The Market 🇨🇳 China

LACTATE DEHYDROGENASE ISOENZYMES

Changsha Sinocare Inc. · 🇨🇳 China
Devices (same UDI-DI)
1
Certificates
0
Countries
0
Notified Bodies
0

Basic Information

Primary DI
D-02B0011YE
Basic UDI-DI Code
B-02B0011YE
Reference
1T001
Device Types
Single use
Regulation
Eu Ivdd
Classification
Eu Ivd General
Status
On The Market
Manufacturer
Changsha Sinocare Inc.

Additional Description

The Myocardial Enzyme Reagent Kit (CK, CK-MB, LDH, a -HBDH) is intended to quanitatively determine the activity of creatine kinase (CK, creatine kinase - MB (CKMB),lactate dehydrogenasein (LDH) and α -hydroxybutyrate dehydrogenase (a-HBDH) in human serum. Cinicaly, It is mainly used as an aid in the diaanosis of viral mvocarditis and mvocardial infarction. Creatine kinase (CK) is predominantly found in skeletal muscles and cardiac muscles, and also exists in brain tissue.Ck becomes more activate wthin 2 - 4h after acute myocardialinfarction, and may raise to 10 - 20 imes the upper imit of normallevel. Elevation of creatine kinase - MB (CKMB) is a widely recognized important indicator which helps to diagnose acute myocardial infarction and to confirm whether there is myocardial necrosis. Lactate dehydrogenasein (LDH) is an important enzyme during glycolysis, catalyzing the interconversion of lacic dehydrogenase and pyruvic acid. The increase of LDH is usualy seen in many diseases such as myocardia, hepatitis, hemolysis and tumor, etc. a -hvdroxvbuibyrate dehvdrogenase (a -nBDH)is one ofthe mvocardial enzymes, which universalv exists in mammals and is mainy distributed in cardiomyocyte,leukocyte, kidney, etc. The increase of a -HBDH is usually seen in diseases such as acute myocardial infarction, muscle injury, acute hepatitis, leukemia and cancer, etc.

CND Nomenclature Codes

Code Description
W01010121 LACTATE DEHYDROGENASE ISOENZYMES
W01010118 HYDROXYBUTYRATE DEHYDROGENASE
W0102160701 CREATINE KINASE - MB MASS - RT & POC

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