510(k) Report

Devices descending from K001364

46 later devices reach BD Directigen Flu a+B through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K063689BD Directigen EZ Flu a+B TestBecton, Dickinson & CO20072—
+1K062109Binaxnow Influenza a & B TestBinax, Inc.200682
+1K041626Immunocard Stat! Flu a & BMeridian Bioscience, Inc.20051—
+1K031899Quickvue Influenza a+B TestQuidel Corp.200334—
+2K101461BD Directigen EX Flu a+BBecton, Dickinson and Company20100—
+2K101529BD Directigen EZ Flu a+B AssayBecton, Dickinson & CO20100—
+2K092349Clearview Exact II Influenza a & B TestInverness Medical, Inc.20102—
+2K092698Quickvue Influenza a+B TestQuidel Corp.200924—
+2K092223Modification to: Binaxnow Influenza a & B TestBinax, Inc.20091—
+2K071591Ramp Influenza a/B AssayResponse Biomedical Corp.20081—
+2K071657Tru FluMeridian Bioscience, Inc.20070—
+2K051244Genzyme Osom Influenza a & B TestGenzyme Corp.20063—
+2K053146Quickvue Influenza a + B TestQuidel Corp.200527—
+3K133411Alere Binaxnow Influenza a & B CardAlere Scarborough, Inc D/B/A Binax, Inc.20130—
+3K121797BD Veritor (TM) System for Rapid Detection of Flu a+BBecton, Dickinson and Company20126—
+3K120049BD Veritor System for the Rapid Detection of Flu a+BBecton, Dickinson and Company20126—
+3K112277BD Veritor (TM) System for Rapid Detection of Flu a+BBecton, Dickinson and Company2011201
+3K103610Clearview Exact II Influenza a & B TestAlere Scarborough, Inc D/B/A Binax, Inc.20111—
+3K083746Biosign Flu a+BPrinceton BioMeditech Corp.201003
+3K093116Modification to: Ramp Influenza a/B AssayResponse Biomedical Corp.20090—
+3K083278Avc a/H5N1 Flu TestArbor Vita Corportation20090—
+3K061508Osom Influenza a&B TestGenzyme Corp.20062—
+4K223016BD VeritorTM System for Rapid Detection of Flu A+B CLIA-Waived KitBd20232—
+4K180438BD Veritor System for Rapid Detection of Flu A + B CLIA waived kitBd201852
+4K160164BD Veritor System for Rapid Detection of Flu A + B Labratory KitBecton, Dickinson & CO20160—
+4K160161BD Veritor System for Rapid Detection of Flu A + B CLIA waived kitBecton, Dickinson & CO20169—
+4K152870BD Veritor System for the Rapid Detection of Flu A + B CLIA waived kitBecton, Dickinson and Co.201510—
+4K152874BD Veritor System for the Rapid Detection of Flu A + B Laboratory kitBecton, Dickinson and Co.20151—
+4K151291BD Veritor (TM) System for the Rapid Detection of Flu A+BBecton, Dickinson and Company201511—
+4K151301BD Veritor™ System Flu A+B AssayBecton, Dickinson and Company20152—
+4K133637Alere Influenza a & B TestAlere Scarborough, Inc D/B/A Binax, Inc.20130—
+4K133140BD Veritor System for the Rapid Detection of RSVBecton, Dickinson & CO20130—
+4K133138BD Veritor™ System Flu A+B AssayBecton, Dickinson & CO20133—
+4K132693BD Veritor™ System Flu A+B AssayBecton, Dickinson and Company20133—
+4K132692BD Veritor System for the Rapid Detection of Flu a+BBecton, Dickinson and Company201317—
+4K132259BD Veritor System for the Rapid Detection of Flu a+BBecton, Dickinson and Company201319—
+4K132256BD Veritor System for the Rapid Detection of Flu a+BBecton, Dickinson and Company20135—
+4K092633Osom Influenza a&B Test , Model PN190Genzyme Corporation20091—
+5K232434BD Veritor™ System for Rapid Detection of Flu A+B CLIA Waived KitBd20231—
+5K191514CareStart Flu A&B PlusAccess Bio, Inc.20201—
+5K162642Alere BinaxNOW Influenza A & B Card 2, Alere Reader, Alere BinaxNOW Influenza A & B Card…Alere Scarborough, Inc.20172—
+5K123182Osom Influenza a&B Test Model 190SEKISUI Diagnostics, LLC20120—
+6K252283Nano-Check Influenza A+B TestNano-Ditech Corporation20260—
+6K250398Innovita Flu A/B Antigen Rapid TestInnovita (Tangshan) Biological Technology Co., Ltd.20250—
+6K173502Alere BinaxNOW Influenza A & B Card 2, Alere Reader, Alere BinaxNOW Influenza A & B Card…Alere Scarborough, Inc.20171—
+7K181853Alere BinaxNOW Influenza A & B Card 2, Alere ReaderAlere Scarborough, Inc.20180—