510(k) Report

Devices descending from K882629

15 later devices reach Directigen Respiratory Syncytial Virus Test Kit through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K032166Binax Now RSV Test, Model 430-000 and Binax Now Nasopharyngeal Swab Accessory Pack…Binax, Inc.200392
+1K022133BD Directigen EZ RSV KitBecton, Dickinson & CO2002111
+1K021789Quicklab RSVIntegrated Biotechnology Corp.20020—
+1K021172RSV OiaThermo Biostar, Inc.20023—
+2K101514BD Directigen EZ RSVBecton, Dickinson & CO20100—
+2K061008Quickvue RSV (20 Test Kit), Model 20193; (2 Test Kit), Model 20199Quidel Corp.20066—
+2K041445Immunocard Stat! RSV Model #750630Meridian Bioscience, Inc.20041—
+2K023779RSV OiaThermo Biostar, Inc.20032—
+3K101918Quickvue RSV 10Quidel Corp.20104—
+3K071101Tru RSVMeridian Bioscience, Inc.20070—
+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