510(k) Report

Devices descending from K946158

6 later devices reach Incstar Epstein-Barr Nuclear Antigen (Ebna_ Igg Elisa Kit through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K040120Diasorin Liaison Ebna Igg, Liaison Vca Igg, Liaison Vca Igm AssaysDiaSorin, Inc.20054—
+1K983841Biotest Anti-Ebv Recombinant, Ebna IggBiotest Diagnostics Corp.19990—
+2K233606ADVIA Centaur EBV-VCA IgMBiokit, S.A.20240—
+2K233605ADVIA Centaur EBV-EBNA IgGBiokit, S.A.20240—
+2K162961LIAISON® VCA IgG and LIAISON® VCA IgG Serum Control Set; LIAISON® EBNA IgG and LIAISON®…DiaSorin, Inc.20170—
+2K161522LIAISON EBV IgM Serum Control SetDiaSorin, Inc.20160—