mariPOC® Gastro control samples

Primary DI

06430080370535

Basic UDI-DI Code

6430080372017MCCE

Reference

2017MC

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. 2017MC mariPOC® Gastro control samples are used with 2017M, 2027M and 2037M test configuration packages.

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