Eu Ivdr Eu Ivd Class B On The Market

ALT/GPT

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

Basic Information

Primary DI
05204309122899
Basic UDI-DI Code
5204309000007NQ
Reference
1419-0080
Device Types
None provided
Regulation
Eu Ivdr
Classification
Eu Ivd Class B
Status
On The Market
Manufacturer
Medicon Hellas SA

Additional Description

Reagent kit for In Vitro quantitative automated measurement by trained laboratory professionals of the activity of Alanine Aminotransferase (EC 2.6.1.2) in samples of human serum or plasma from the general population. Measurements of ALT are intended to be used by licensed physicians, along with other in vitro and in vivo tests and physical examination, as an aid in the evaluation of liver health. This product has been packed for use with Diatron Pictus® P700/P500 or Medicon MEDILYZER® F/BX automated analyzers.

CND Nomenclature Codes

Code Description
W01010103 ALANINE AMINO-TRANSFERASE

Available In Countries

🇧🇬 Bulgaria 🇬🇷 Greece 🇭🇺 Hungary 🇮🇹 Italy 🇵🇹 Portugal

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