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