510(k) Report

Devices descending from K022133

11 later devices reach BD Directigen EZ RSV Kit through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K101514BD Directigen EZ RSVBecton, Dickinson & CO20100—
+1K041445Immunocard Stat! RSV Model #750630Meridian Bioscience, Inc.20041—
+1K032166Binax Now RSV Test, Model 430-000 and Binax Now Nasopharyngeal Swab Accessory Pack…Binax, Inc.200392
+2K071101Tru RSVMeridian Bioscience, Inc.20070—
+2K061008Quickvue RSV (20 Test Kit), Model 20193; (2 Test Kit), Model 20199Quidel Corp.20066—
+3K101918Quickvue RSV 10Quidel Corp.20104—
+3K070747Quick Vue RSV Test, Models 20193, 20199Quidel Corp.20075—
+4K132456BD Veritor (TM) System for Rapid Detection of RSVBecton, Dickinson and Company20130—
+4K121633BD Veritor (TM) System for the Rapid Detection of RSVBecton, Dickinson and Company20122—
+5K130398Sofia (R) RSV FiaQuidel Corp.20131—
+6K162911Sofia RSV FIA on Sofia 2 analyzerQuidel Corporation201701