Eu Ivdd Eu Ivd General On The Market 🇨🇳 China

BILE ACIDS

Devices (same UDI-DI)
1
Certificates
0
Countries
6
Notified Bodies
0

Basic Information

Primary DI
06975225462718
Basic UDI-DI Code
B-06975225462718
Reference
DTSH020108
Device Types
None provided
Regulation
Eu Ivdd
Classification
Eu Ivd General
Status
On The Market

Additional Description

This kit is intended for the in vitro quantitative detection of total bile acid (TBA) in human serum. TBA levels were significantly higher in patients with acute hepatitis, even more than 10 to 100 times the normal level. In patients with chronic hepatitis, if TBA levels is above 20 μmol/L, it should be diagnosed as chronic active hepatitis. Serum TBA was significantly higher when alcoholic liver disease generate serious liver injury, and mild, moderate damage increase is not obvious. Determination of serum TBA in the diagnosis of liver toxicity than conventional liver function tests. Extrahepatic bile duct obstruction, intrahepatic cholestasis including acute hepatitis, biliary cirrhosis early, neonatal cholestasis, cholestasis of pregnancy etc. lead TBA increased.

CND Nomenclature Codes

Code Description
W01010202 BILE ACIDS

Available In Countries

🇧🇪 Belgium 🇩🇪 Germany 🇫🇷 France 🇮🇹 Italy 🇳🇱 Netherlands 🇸🇪 Sweden

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