FDA.reportPublic FDA data

Becton, Dickinson and Company, BD Biosciences

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30273945063027394506Becton, Dickinson and Company, BD Biosciences1N2027-01-01155 North McCarthy Boulevard Milpitas CA US 95035
30152926433015292643BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES1Y2026-01-012600 Melksee Street San Diego CA US 92154
29168372916837Becton, Dickinson and Company, BD Biosciences1N2020-04-252350 QUME DR. San Jose CA US 95131

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
781942028140746K981342ABBOTT CELL-DYN 4000 IMMUNOPIT (CD61) ASSAYGKZ1998-06-29
3178942028140746K981342ABBOTT CELL-DYN 4000 IMMUNOPIT (CD61) ASSAYGKZ1998-06-29
781941106511780K980858MULTITEST CD3/CD16+56/CD45/CD19 REAGENT AND MULTITEST IMK KIT LYSING SOLUTIONGKZ1998-05-22
3178941106511780K980858MULTITEST CD3/CD16+56/CD45/CD19 REAGENT AND MULTITEST IMK KIT LYSING SOLUTIONGKZ1998-05-22
781941359494826K973483FACSCOMP SOFTWARE AND CALIBRITE BEADS FOR USE IN FLOW CYTOMETER INSTRUMENT SETGKZ1998-02-17
3178941359494826K973483FACSCOMP SOFTWARE AND CALIBRITE BEADS FOR USE IN FLOW CYTOMETER INSTRUMENT SETGKZ1998-02-17
781941998688778K971205TRI TEST REAGENT CD4 FIT C/CD8 PE/CD3 PERCP WITH TRUCOUNT ABSOLUTE COUNT TUBESGKZ1997-12-01
3178941998688778K971205TRI TEST REAGENT CD4 FIT C/CD8 PE/CD3 PERCP WITH TRUCOUNT ABSOLUTE COUNT TUBESGKZ1997-12-01
781941064288628K971110TRITEST REAGENT CD3 FITC/CD16+CD56 PE/CD45 PERCP;WITH TRUCOUNT ABSOLUTE COUNT TUBESGKZ1997-11-25
3178941064288628K971110TRITEST REAGENT CD3 FITC/CD16+CD56 PE/CD45 PERCP;WITH TRUCOUNT ABSOLUTE COUNT TUBESGKZ1997-11-25
781941384647625K970836TRUCOUNT ABSOLUTE COUNT TUBES/COUNTING CONTROL BEADSGKZ1997-08-26
3178941384647625K970836TRUCOUNT ABSOLUTE COUNT TUBES/COUNTING CONTROL BEADSGKZ1997-08-26
781941806840734K970742TRITEST CD3 FITC/CD19 PE/CD45 PERCP REAGENT WITH TRUCOUNT ABSOLUTE COUNT TUBESGKZ1997-10-22
3178941806840734K970742TRITEST CD3 FITC/CD19 PE/CD45 PERCP REAGENT WITH TRUCOUNT ABSOLUTE COUNT TUBESGKZ1997-10-22
781941130378748K970326TRITEST REAGENT CD3 FITC/CD8 PE/CD45 PERCP;WITH TRUCOUNT ABSOLUTE COUNT TUBESGKZ1997-11-21
3178941130378748K970326TRITEST REAGENT CD3 FITC/CD8 PE/CD45 PERCP;WITH TRUCOUNT ABSOLUTE COUNT TUBESGKZ1997-11-21
781941428533714K963963MULTISET SOFTWARE FOR AUTOMATED FLOW CYTOMETRIC DATA ANALYSISGKZ1996-12-12
3178941428533714K963963MULTISET SOFTWARE FOR AUTOMATED FLOW CYTOMETRIC DATA ANALYSISGKZ1996-12-12
781941750196610K953302FACS LOADER SYSTEMGKZ1995-11-20
3178941750196610K953302FACS LOADER SYSTEMGKZ1995-11-20
781941423731790K950057TRITEST CONTROL REAGENT IGG1 FITC/IGFG1 PE/CD45 PERCPGKZ1995-08-22
3178941423731790K950057TRITEST CONTROL REAGENT IGG1 FITC/IGFG1 PE/CD45 PERCPGKZ1995-08-22
781942012398865K946055TRITEST REAGENT CD3 FITC/CD4 PE/CD45 PERCPGKZ1996-02-20
781941550916376K933486FASCOUNT SYSTMEGKZ1994-09-09
3178941550916376K933486FASCOUNT SYSTMEGKZ1994-09-09
781941492615083K924587SIMULTEST CD3/ANTI-HLA-DRGKZ1993-08-05
3178941492615083K924587SIMULTEST CD3/ANTI-HLA-DRGKZ1993-08-05
781941867469915K923790FACSORT FLOW CYTOMETERGKZ1993-09-01
781941967909349K913192SIMULTEST(TM) IMK-LYMPHOCYTEGKZ1992-02-06
3178941967909349K913192SIMULTEST(TM) IMK-LYMPHOCYTEGKZ1992-02-06
781941722322524K904390ANTI-HUMAN LEU-2A (CD8) PEGKZ1990-12-17
3178941722322524K904390ANTI-HUMAN LEU-2A (CD8) PEGKZ1990-12-17
781941476606197K900802ANTI-HUMAN LEU-3A (CD4) FITCGKZ1990-05-15
3178941476606197K900802ANTI-HUMAN LEU-3A (CD4) FITCGKZ1990-05-15
781941625036503K900078SIMULTEST IMK PLUS(TM)GKZ1990-04-02
3178941625036503K900078SIMULTEST IMK PLUS(TM)GKZ1990-04-02
781941686548868K880636RETICCOUNT SOFTWAREGKL1988-03-21
3178941686548868K880636RETICCOUNT SOFTWAREGKL1988-03-21
781941450633012K872166FACSCAN FLOW CYTOMETER - RETICCOUNT RETI. ENU. KITGKL1987-09-30
781941626927089K864893ANTI-CYTOKERATIN MONOCLONAL ANTIBODYLYE1988-07-07
3178941626927089K864893ANTI-CYTOKERATIN MONOCLONAL ANTIBODYLYE1988-07-07
781941502302874K851639ANTI-LEU-12 B CELL REAGENTLJD1986-07-02
3178941502302874K851639ANTI-LEU-12 B CELL REAGENTLJD1986-07-02
781941677055159K842218ANTI-LEU-4 FITC LYSIN C BUFFERLIZ1984-12-27
3178941677055159K842218ANTI-LEU-4 FITC LYSIN C BUFFERLIZ1984-12-27
3178941039964371K201814BD FACSLyric Flow Cytometer (3-1, 4-2, 4-2-2, 4-3-3 and 4-3-5 optical configurations), BD FACSDuet Sample Preparation System, BD FACS Universal Loader, BD FACSuite Clinical software, BD Multitest 6-Color Assay Modules, BD Multitest 4-Color Assay Modules, BD FACSFlow Sheath Fluid, BD CS&T Beads, BD FC Beads 7-Color KitOYE2020-09-28
781941957771682K170974BD FACSLyric Flow Cytometer (3-1, 4-2, 4-2-2 and 4-3-3 optical configurations), BD FACSuite Clinical Software, BD Multitest 6-Color Assays, BD Multitest 4-Color Assays, BD Multitest 6-Color TBNKOYE2017-07-03
3178941957771682K170974BD FACSLyric Flow Cytometer (3-1, 4-2, 4-2-2 and 4-3-3 optical configurations), BD FACSuite Clinical Software, BD Multitest 6-Color Assays, BD Multitest 4-Color Assays, BD Multitest 6-Color TBNKOYE2017-07-03
781941069208421K150815BD FACSPresto System, BD FACSPresto CD4/Hb Cartridge, BD FACSPresto CD4/Hb Cartridge KitPMG2015-12-17
3178941069208421K150815BD FACSPresto System, BD FACSPresto CD4/Hb Cartridge, BD FACSPresto CD4/Hb Cartridge KitPMG2015-12-17
781942040669252K141468BD FACSCanto II flow cytometer (4-2-2 and 5-3 configurations), BD FACSCanto flow cytometer (4-3-3 configuration)OYE2015-02-27
3178942040669252K141468BD FACSCanto II flow cytometer (4-2-2 and 5-3 configurations), BD FACSCanto flow cytometer (4-3-3 configuration)OYE2015-02-27
781941295434363K131301BD FACS SAMPLE PREP ASSISTANT IIIPER2013-08-02
3178941295434363K131301BD FACS SAMPLE PREP ASSISTANT IIIPER2013-08-02
781941718064941K090967BD MULTITEST 6-COLOR TBNK REAGENT, MODEL 644611GKZ2009-07-31
3178941718064941K090967BD MULTITEST 6-COLOR TBNK REAGENT, MODEL 644611GKZ2009-07-31
781941967275850K081213BD FACSCOUNT CD4 REAGENTS WITH MODEL 339010GKZ2008-08-14
3178941967275850K081213BD FACSCOUNT CD4 REAGENTS WITH MODEL 339010GKZ2008-08-14
781941155866452K071143BD TRITEST CD3/CD4/CD45, MODEL 340383GKZ2007-06-06
3178941155866452K071143BD TRITEST CD3/CD4/CD45, MODEL 340383GKZ2007-06-06
781941597133164K062087BD FACSCANTO II FLOW CYTOMETER, MODEL 338960; (5-3), MODEL 339473; (4-2-2), MODEL 338962GKZ2006-09-14
3178941597133164K062087BD FACSCANTO II FLOW CYTOMETER, MODEL 338960; (5-3), MODEL 339473; (4-2-2), MODEL 338962GKZ2006-09-14
781941919720122K050191MODIFICATION TO BD FACSCANTO SYSTEM WITH BD FACSCANTO CLINICAL SOFTWAREPER2005-02-22
3178941919720122K050191MODIFICATION TO BD FACSCANTO SYSTEM WITH BD FACSCANTO CLINICAL SOFTWAREPER2005-02-22
781941142065312K040725BD FACSCANTO SYSTEMGKZ2004-09-10
3178941142065312K040725BD FACSCANTO SYSTEMGKZ2004-09-10
3178942045182205K040026BD FACS 7-COLOR SETUP BEADSGKZ2004-09-10
781941617598528K010953CELL-DYN 4000 IMMUNO T-CELL (CD3/4/8) ASSAYGKZ2001-06-06
3178941617598528K010953CELL-DYN 4000 IMMUNO T-CELL (CD3/4/8) ASSAYGKZ2001-06-06
781942052923333K000897CALIBRITE PERCP-CY5.5 BEADS AND FACSCOMP SOFTWAREGKZ2000-05-05
3178942052923333K000897CALIBRITE PERCP-CY5.5 BEADS AND FACSCOMP SOFTWAREGKZ2000-05-05
781941317168908BK970046
3178941317168908BK970046
781941724802846BK970038
3178941724802846BK970038
781941748821355BK960087
3178941748821355BK960087
3178941199033933BK230835
3178942028343818BK210652
781941341084378BK180245
781941798504941BK150307
3178941798504941BK150307
781941029013219BK110037
3178941029013219BK110037
781941163657443BK050073
3178941163657443BK050073
781941120206901
781941363948523
781941503560705
781941868279576
781941940965737
781941973138894
3178941120206901
3275861120206901
3178941503560705
3178941708690993
3178941868279576
3178941940965737
3178941973138894
3178942007171399

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
GKZ522009-07-31
OYE52020-09-28
PER42013-08-02
GKL31988-03-21
PMG22015-12-17
LYE21988-07-07
LJD21986-07-02
LIZ21984-12-27