Eu Ivdr Eu Ivd Class C On The Market

CK

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

Basic Information

Primary DI
05204309161195
Basic UDI-DI Code
5204309000014NM
Reference
1419-0090
Device Types
None provided
Regulation
Eu Ivdr
Classification
Eu Ivd Class C
Status
On The Market
Manufacturer
Medicon Hellas SA

Additional Description

Reagent kit for In Vitro quantitative automated determination by trained laboratory professionals of the activity of Creatine Kinase - CK (EC 2.7.3.2) in samples of human serum or plasma. Measurements of CK 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 myocardial infarction and conditions involving muscle tissue damage. 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
W01010113 CREATINE KINASE - TOTAL

Available In Countries

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

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