830194 - LABOVIDA - BOA VISTA RR - BRASIL 30/11/22 15:10:42

GeneXpert® Dx System
Installation Qualification Report

This report provides documented evidence of the installation of this GeneXpert® Dx System.

System Information
Software Version Status
GeneXpert® Dx System 4.8 Pass
Java Runtime Environment 1.7.0_60 Pass
GX_Utils.DLL 0.8.4.0 Pass
SQL Database Microsoft SQL Server 11.00.5058 Pass
Database gx_db 3.0.7.0 Pass
Operating System Windows 7 6.1 Service Pack 1 Pass
CIT Plug-In 1 Pass

Instrument Information
Instrument A
Instrument S/N Gateway Firmware
830194 2.0.18

Module Name Module S/N Module Firmware Internal Temp Status

°C
A1 618778 3.3.3 25.9 Pass
A2 744476 3.3.3 20.5 Pass

Shaded Modules = Reporter is out of calibration.

Available Assays
Assay Name Version Assay Type
Xpert CT_NG 3 In Vitro Diagnostic
Xpert FII & FV Combo 1 In Vitro Diagnostic
Xpert Flu CE-IVD 7 In Vitro Diagnostic
Xpert GBS G3 4 In Vitro Diagnostic
Xpert HPV HR_16_18-45 1 In Vitro Diagnostic
Xpert Xpress Flu-RSV 5 In Vitro Diagnostic
Xpert Xpress SARS-CoV-2 2 In Vitro Diagnostic
Xpert Xpress_Flu 5 In Vitro Diagnostic
Xpert Xpress_RSV 5 In Vitro Diagnostic
GxReliabilityTestFATA NA Research

GeneXpert® Dx System Version 4.8 Page 1 of 2

830194 - LABOVIDA - BOA VISTA RR - BRASIL 30/11/22 15:10:42

GeneXpert® Dx System
Installation Qualification Report

Installation of networked instruments complies with the setup requirements specified in the GeneXpert® Dx
System Operator Manual, 'Installation' section.

Verified by Date
This IQ is acceptable if all System Information and Instrument Information are listed as 'Pass'. All instrument
modules that are listed as 'Pass' are available for use.

Acceptance: [ ] Acceptable [ ] Not Acceptable

Performed by Date

Reviewed and approved by Date

GeneXpert® Dx System Version 4.8 Page 2 of 2