Appendices; Disposal Information; Declaration Of Conformity; Glossary - STAT-Dx DiagCORE Respiratory Panel 2 Instructions For Use Manual

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14.1 Disposal information

Dispose in sealed containers at licensed waste disposal site. Dispose of contents/container
according with local/regional/national/international regulations.

14.2 Declaration of conformity

Name and address of the legal manufacturer:
STAT-Dx Life, S.L.
Baldiri Reixac 4-8
08028 Barcelona, Spain
An up-to-date Declaration of Conformity can be requested from STAT-Dx Life, S.L.

14.3 Glossary

Amplification curve: Graphical representation of the RT-real time PCR amplification data
Analytical Module (AM): The main DiagCORE
tests on DiagCORE
Modules can be connected to one Operational Module.
DiagCORE
Analytical Module. The Operational Module includes elements that provide connectivity to the
Analytical Module and enable user interaction with the DiagCORE Analyzer. The Analytical Module
contains the hardware and software for sample testing and analysis.
DiagCORE
loaded reagents required for the complete execution of fully automated molecular assays for the
detection of respiratory pathogens.
IFU: Instructions For Use.
Main port: In the DiagCORE
Nucleic acids: Biopolymers, or small biomolecules composed of nucleotides, which are monomers
made of three components; a 5-carbon sugar, a phosphate group and a nitrogenous base.
Operational Module (OM): The dedicated DiagCORE
interface for one to four Analytical Modules (AM).
PCR: Polymerase Chain Reaction
RT: Reverse Transcription
Swab port: In the DiagCORE
User: A person who operates the DiagCORE
in the intended way.
64 DiagCORE Respiratory Panel 2 Instructions for Use

Appendices

cartridges. It is controlled by the Operational Module. Several Analytical
®
Analyzer: The DiagCORE
®
Respiratory Panel 2 cartridge: A self-contained disposable plastic device with all pre-
®
respiratory panel 2 cartridge, inlet for transport medium liquid samples.
®
Respiratory Panel 2 cartridge, inlet for dry swabs.
®
Analyzer hardware module, in charge of executing
®
Analyzer consists of an Operational Module and an
®
® Analyzer hardware that provides the user
Analyzer/ DiagCORE
®
Respiratory Panel 2 cartridge
®