mariPOC® RTI control samples

Primary DI

06430080370498

Basic UDI-DI Code

6430080371104MCBN

Reference

1104MC

Device Types

Single use

Regulation

Eu Ivdr

Classification

Eu Ivd Class A

Status

On The Market

Manufacturer

ArcDia International Oy Ltd

The intended use of the mariPOC® control samples is to provide follow-up data about the functionality of the mariPOC® Analyser and analysis process. The control samples are recommended to be run once a week or when needed for troubleshooting. The control samples are neither used to calibrate nor to verify the performance characteristics of the mariPOC® devices by the user. A control sample package includes one negative control (an empty tube) and one positive control (dried analyte/s in a tube). A positive control includes analytes for the test reagent configurations on the test plate that it is intended to be used with it. 1104MC mariPOC® RTI control samples are used with 1194M, 1164M, 1184M, 1154M, 1214M and 1174M test configuration packages.

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