REDx™ Mycoplasma genitalium Positive Control is formulated with whole inactivated bacterial and human fibroblast cells. REDx™ Mycoplasma genitalium Positive Control can be utilized as an external sample to monitor the process of Mycoplasma genitalium nucleic acid detection assays including extraction and purification, amplification, and detection.REDx™ Mycoplasma genitalium Positive Control does not have an assigned value (“unassayed”). It is required that each laboratory establish an acceptance range for each lot of REDx™ Mycoplasmagenitalium Positive Control and for each assay procedure with which it is intended to be run, prior to routine use in the laboratory