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Chapter 2 safety and regulatory considerations, Intended use, Chapter 2: safety and regulatory considerations – Luminex MAGPIX Installation and Hardware User (IVD) User Manual

Page 15: Safety and regulatory considerations

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CHAPTER 2

Safety and Regulatory
Considerations

Become familiar with the safety information in this chapter before using MAGPIX. This
system contains electrical and mechanical components that, if handled improperly, are
potentially harmful. In addition, biological hazards may be present during system
operation. Therefore, Luminex recommends that all system users become familiar with the
specific safety advisories below in addition to adhering to standard laboratory safety
practices. Do not perform procedures on MAGPIX that are not specifically described in
this manual, unless you are directed to do so by Luminex Technical Support.

Intended Use

The MAGPIX system is a clinical multiplex test system intended to measure and sort
multiple signals generated in an in vitro diagnostic assay from a clinical sample. This
instrument system is used with a specific assay to measure multiple analytes that aid in
diagnosis. The device includes a signal reader unit, raw data storage mechanisms, data
acquisition software and software to process detected signals.