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Safety and regulatory considerations, Intended use, Regulatory labels and warnings – Luminex MAGPIX Hardware and Installation Manual User Manual

Page 16: Chapter 2 safety and regulatory considerations, Intended use regulatory labels and warnings, Chapter 2: safety and regulatory considerations

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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 for research use only and is not for use in diagnostic procedures
within the United States. The system has not been cleared or approved for clinical use by the
US Food and Drug Administration (FDA). The MAGPIX system is CE marked for in vitro
diagnostic use within the European Union (EU).

Regulatory Labels and Warnings

The following fuse caution label appears on MAGPIX.

Chapter 2: Safety and Regulatory

Considerations

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