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Intended Use
The MiOXSYS Test performed on the MiOXSYS Analyzer is a rapid in vitro diagnostic semen analysis test utilizing an electrochemical technology for the qualitative measurement (millivolts mV) of static Oxidation Reduction Potential (sORP) in human semen.
The MiOXSYS System is intended for professional use in conjunction with standard semen analysis parameters (ejaculate volume, total sperm, sperm concentration, total motility, progressive motility, and morphology) as an aid to assess semen quality. For in vitro diagnostic use only.
The MiOXSYS System is intended for use in hospital, reference or state laboratory settings. The device is not intended for point-of-care use.
The MiOXSYS System is indicated for use in adult males aged 21-45 yrs old who are undergoing semen analysis.
The MiOXSYS System is intended to be used together with MiOXSYS sensors for probe application and connecting to analyzer.
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