Eu Ivdr Eu Ivd Class A On The Market 🇫🇮 Finland

mariPOC® Software

ArcDia International Oy Ltd · 🇫🇮 Finland
Devices (same UDI-DI)
1
Certificates
0
Countries
0
Notified Bodies
0

Basic Information

Primary DI
06430080370429
Basic UDI-DI Code
643008037AD1-ST3
Reference
AD1-S
Device Types
None provided
Regulation
Eu Ivdr
Classification
Eu Ivd Class A
Status
On The Market

Additional Description

The intended use of the mariPOC® Software named ArcDiagnoser™ is to archive and process sensory data of the mariPOC® Analyser measured from mariPOC® test reagents on test plate(s), as well as the associated patient information, in accordance with the commands fed by the user through the graphical user interface or laboratory information connection. mariPOC® Software functions as an in vitro diagnostic device when used in combination with mariPOC® test reagents and Analyser. mariPOC® Software is a stand-alone software for the mariPOC® test system, that provides the main graphical user interface (GUI), and additionally controls the automated functions of the mariPOC® Analyser and the end user operations. It objectively reports the results qualitatively and/or semiquantitatively on the graphical user interface, and enables data transfer between other IT systems.

CND Nomenclature Codes

Code Description
W0201020292 LIMITED PANEL IMMUNOCHEMISTRY ANALYSERS - IVD MEDICAL DEVICE SOFTWAE

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