510(k) Report

Devices descending from K230440

1 later device reach Xpert® Xpress CoV-2 plus through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K242109Xpert® Xpress CoV-2 plus (XPRS-COV2-10)Cepheid®20250—