Eu Ivdr Eu Ivd Class B On The Market

AST/GOT

Devices (same UDI-DI)
5
Certificates
0
Countries
3
Notified Bodies
0

Basic Information

Primary DI
05204309087310
Basic UDI-DI Code
5204309000009NU
Reference
1419-0072
Device Types
None provided
Regulation
Eu Ivdr
Classification
Eu Ivd Class B
Status
On The Market
Manufacturer
Medicon Hellas SA

Additional Description

Reagents for In Vitro automated quantitative measurement of the activity of Aspartate Aminotransferase - AST/GOT (EC 2.6.1.1) in samples of human serum or plasma from the general patient population. Measurements of AST/GOT are to be used along with other in vitro and in vivo tests and physical examination by licensed physicians, as an aid in the evaluation of liver health and the screening for, detection, differential diagnosis, severity assessment and monitoring of hepatic diseases. This product has been packed for use with Diatron Pictus® P700/P500 or Medicon MEDILYZER® F/BX analyzers. For in vitro diagnostic use only by trained laboratory professionals.

CND Nomenclature Codes

Code Description
W01010110 ASPARTATE AMINO-TRANSFERASE

Available In Countries

🇧🇬 Bulgaria 🇬🇷 Greece 🇭🇺 Hungary

Related Devices

The Basic UDI-DI associated with this device has 5 devices in total. Below are some other devices sharing the same Basic UDI-DI.

Similar Devices

Other on-the-market devices with the same classification (Eu Ivd Class B) and regulation (EU IVDR).

View all