510(k) Report

Devices descending from K231481

4 later devices reach Xpert Xpress CoV-2/Flu/RSV plus through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K250996Xpert Xpress CoV-2/Flu/RSV plusCepheid®20250—
+1K242071Xpert Xpress CoV-2/Flu/RSV plusCepheid20252—
+2K252932Fast PCR Mini Respiratory PanelAutonomous Medical Devices Incorporated20260—
+2K250995Xpert Xpress CoV-2/Flu/RSV plusCepheid®20250—