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

mariPOC® Analyser

ArcDia International Oy Ltd · 🇫🇮 Finland
Devices (same UDI-DI)
1
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Basic Information

Primary DI
06430080370412
Basic UDI-DI Code
643008037AD7-020HF
Reference
AD7-020
Device Types
None provided
Regulation
Eu Ivdr
Classification
Eu Ivd Class A
Status
On The Market

Additional Description

The intended use of the mariPOC® Analyser AD7-020 is automated sample dispensing fluorometry based on two-photon excitation assay technique. The fluorometer measures, separation-free, fluorescence signal from the surface of individual microparticles able to scatter excitation light and from the aqueous solution around the microparticles from the reaction wells of mariPOC® test plates. mariPOC® Analyser functions as an in vitro diagnostic device when used in combination with mariPOC® test reagents. The Analyser's functions are automated and controlled by the external mariPOC® Software and the embedded software that control the measurement process. The sensory data is quantitative in nature and the fluorescence brightness of the particles depends quantitatively on the target molecule concentration. The sensory data is transmitted by the embedded software to the mariPOC® Software, where it is processed into objective results. The results are presented on the graphical user interface of the mariPOC® Software either qualitatively or semi-quantitatively.

CND Nomenclature Codes

Code Description
W0201020299 LIMITED PANEL IMMUNOCHEMISTRY ANALYSERS - OTHER

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