Eu Ivdr Eu Ivd Class B On The Market

ASO

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

Basic Information

Primary DI
05204309133901
Basic UDI-DI Code
5204309000008NS
Reference
1419-1066
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 measurement of the concentration of Antistreptolysin-O (ASO) in samples of human serum or plasma from the general patient population. Measurements of ASO are to be used along with other in vitro and in vivo tests and physical examination by licensed physicians, as an aid in the diagnosis of post-streptococcal infection complications. 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
W01021104 ANTI-STREPTOLYSIN O (QUANTITATIVE)

Available In Countries

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

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