Focus Diagnostics’ Simplexa™ Adenovirus Molecular Control consists of inactivated adenovirus intended to be used as a control in molecular testing. This control is not intended for use with donor screening tests.

Focus Diagnostics’ Simplexa™ BKV Molecular Control consists of a DNA fragment to a well conserved region of BKV VP2 gene intended to be used as a control in molecular testing. This control is not intended for use as a control with screening tests for the presence of BKV in blood or blood products.

Simplexa™ BKV Quantitation Standards are intended to establish a standard curve with the Simplexa™ BKV assay on the 3M™ Integrated Cycler.

Focus Diagnostics’ Simplexa™ Bordetella Molecular Control consists of a 625 bp DNA fragment containing both the IS481 and IS1001 target regions intended to be used as an unassayed control in molecular testing. This control is not intended for use with donor screening tests.

Focus Diagnostics’ Simplexa™ CMV Molecular Control consists of a DNA fragment containing a well conserved region of CMV UL83 gene intended to be used as a control in molecular testing. This control is not intended for use as a control with screening tests for the presence of CMV in blood or blood products.

Simplexa™ CMV Quantitation Standards are intended to establish a standard curve with the Simplexa™ CMV assay on the 3M Integrated Cycler.

Focus Diagnostics' Simplexa™ Dengue Molecular Control consists of inactivated Dengue virus intended to be used as a control in molecular testing. This control is not intended for use with donor screening tests.

Focus Diagnostics’ Simplexa™ EBV Molecular Control consists of a DNA fragment to a well conserved region of EBV LMP2A gene intended to be used as a control in molecular testing. This control is not intended for use as a control with screening tests for the presence of EBV in blood or blood products.

Simplexa™ EBV Quantitation Standards are intended to establish a standard curve with the Simplexa™ EBV assay on the 3M™ Integrated Cycler.

This set consists of a DNA template and labeled primer pair intended to be used as a process control to detect systemic variation that may arise during the extraction and amplification steps of real-time polymerase chain reaction (PCR) assays. The set is not intended to monitor other real-time PCR processes.