Eu Ivdr Eu Ivd Class B On The Market

MICROALBUMIN

Devices (same UDI-DI)
6
Certificates
0
Countries
4
Notified Bodies
0

Basic Information

Primary DI
05204309087815
Basic UDI-DI Code
5204309000037NZ
Reference
1419-0852
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 quantitative automated determination of the concentration of Albumin in samples of human Urine (Microalbumin) from the general patient population. Measurements of Microalbumin are to be used along with other in vitro and in vivo tests and physical examination by licensed physicians, as an aid for screening, diagnosis and management of kidney disorders. This product has been packed for use with Diatron Pictus® P700/P500 or Medicon MEDILYZER® F/BX automated analyzers. For in vitro diagnostic use only by trained laboratory professionals.

CND Nomenclature Codes

Code Description
W0102010309 ALBUMIN (IC) INCL. UALBUMIN

Available In Countries

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

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