Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3027394506

FEI Number

3027394506

Entity Name

Becton, Dickinson and Company, BD Biosciences

City/State/Country

Milpitas, CA, US

Establishment Address

155 North McCarthy Boulevard, Milpitas, CA 95035, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

Becton Dickinson and Company (Owner Number: 9922032)

Owner / Operator Contact Address

One Becton Drive, Franklin Lakes, NJ 07417, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

BK970038

PMA Number

N/A

All Registered Proprietary Names

BD Trucount Tubes BD Tritest CD3/CD8/CD45 BD FACSComp Software BD Calibrite PerCP-Cy5.5 Beads and Buffer BD Simultest CD3/Anti-HLA-DR FACSCanto Loader BD FACSCanto II w BD FACSCanto clinical sw & BD FACSDiva sw and BDFACSCanto w BDFACSCanto clinical sw and BD FACSDiva sw BD TruCount Tubes BD Tritest CD4/CD8/CD3 BD Tritest Control g1/g1/CD45 BD Trucount Tubes 340676 - BD CD38 PE 340692 - BD CD8 (SK1) FITC 340874 - BD CD11A FITC 341008 - BD CD23 PE 641408 - BD CD45 APC-H7 644139 - BD Anti-Lambda F(Ab')2 FITC 656159 - BD IREM2 APC 658367 - BD CD10 PE (MEM-78) 664522 - BD CD14 (MPhiP9) BV711 664536 - BD Anti-HLA-DR (G46-6) BV786 335813 - BD Anti-HLA-DR PE-Cy7 340712 - BD CD11B PE 340755 - BD Mouse IgG1 FITC 341106 - BD CD117 APC 346581 - BD CD20 PE 649452 - BD CD45RO PE-Cy7 655158 - BD CD43 FITC 659453 - BD Mouse IgG1 (X40) BV421 663191 - BD CD11b (D12) BV605 663801 - BD CD24 (ML5) BV605 665129 - BD CD194 (1G1) BV421 666650 - BD Horizon CD45RA (HI100) BV510 340651 - BD Anti-Bcl-2 PE 340683 - BD CD14 PE 340861 - BD CD57 Biotin 340886 - BD Anti-TCR-1 Gamma/Delta FITC 340942 - BD CD45 APC 341049 - BD CD8 PerCP-Cy5.5 348802 - BD Mouse IgG1 APC-Cy7 642285 - BD Anti-HLA-DR V450 649457 - BD CD45RA PE-Cy7 657709 - BD IgG1 APC-R700 664528 - BD CD4 (SK3) BV786 667245 - BD® Anti TCR-C?2 (SAM.2) APC 340653 - BD CD79A APC 340684 - BD CD14 APC 340700 - BD CD2 FITC 340864 - BD CD19 (4G7) FITC 340887 - BD Anti-TCR-1 Gamma/Delta PE 340944 - BD CD103 FITC 341097 - BD CD138 PerCP-Cy5.5 642921 - BD CD7 V450 649458 - BD CD45RA FITC 657721 - BD Mouse IgG1 BV605 664529 - BD CD5 (L17F12) BV786 665120 - BD CD197 (2-L1-A) APC-R700 339196 - BD IgG1 AmCyan 340672 - BD CD4 APC 340689 - BD Anti-HLA-DR PE 340765 - BD Mouse IgG2a PerCP 340869 - BD CD7 Purified 340952 - BD CD45 PerCP-Cy5.5 641405 - BD CD20 APC-H7 656153 - BD CD49d APC-H7 (9F10) 663788 - BD CD7 (M-T701) BV421 664519 - BD CD4 (SK3) BV711 664533 - BD CD20 (L27) BV786 666660 - BD Horizon CD64 (MD22) BV605 335809 - BD CD56 PE-Cy7 339201 - BD CD19 AmCyan 340662 - BD CD3 PE 340677 - BD CD38 APC 340724 - BD CD56 (NCAM16.2) PE 340853 - BD CD4 Purified 340932 - BD CD22 APC 347213 - BD CD34 PerCP-Cy5.5 655437 - BD CD13 APC 663188 - BD CD4 (SK3) BV605 663986 - BD CD10 (HI10a) BV605 664523 - BD CD38 (HB7) BV711 666646 - BD® CD13 (WM15) PerCP-Cy5.5 666664 - BD HorizonCD235a (GA-R2/HIR2) BV605 338432 - BD CD13 PE-Cy7 340670 - BD CD4 PE 340762 - BD Mouse IgG1 PerCP 340866 - BD CD45 Purified 347207 - BD CD138 APC 348805 - BD CD45 APC-Cy7 655430 - BD CD43 APC-H7 656150 - BD CD24 APC-H7 (ML5) 663196 - BD CD158a (HP-3E4) PE 663995 - BD CD 138 (MI15) APC-R700 666657 - BD Horizon Anti-TCR ?? (11F2) BV421 335816 - BD CD79B PE 340668 - BD CD34 (8G12) FITC 340760 - BD Mouse IgG1 Platelet Control PE 347205 - BD CD138 FITC 348803 - BD CD8 APC-Cy7 649455 - BD CD26 PE 655428 - BD CD200 APC 656147 - BD CD16 FITC CLB-Fc-gran/1 5D2 663194 - BD CD10 (HI10a) PerCP-Cy5.5 663804 - BD Anti-Lambda(1-155-2) BV605 663992 - BD CD5 (L17F12) APC-R700 666654 - BD Horizon CD26 (L272) BV421 335807 - BD CD25 PE-Cy7 339198 - BD CD4 AmCyan 340660 - BD CD14 PerCP 340722 - BD CD19 (SJ25C1) APC 340850 - BD CD15 Purified 341640 - BD CD33 PerCP-Cy5.5 347211 - BD Anti-Epcam PE 655112 - BD CD11c V450 655434 - BD TCR GAMMA / DELTA - 1 PE-Cy7 659479 - BD CD5 (L17F12) BV421 663984 - BD CD138 (MI15) BV421 666644 - BD® CD24 (ML5) PE 666662 - BD Horizon CD34 (563) BV605 241115 - BD Francisella tularensis Antigen 335814 - BD Anti-HLA-DR APC-Cy7 340666 - BD CD34 (8G12) PerCP 340713 - BD CD11C PE 340756 - BD Mouse IgG2a Control PE 346586 - BD Anti-Lambda FITC 649453 - BD CD123 PE 655160 - BD CD45RO FITC 659454 - BD CD4 SK3 BV510 663192 - BD Anti- Kappa (TB28-2) BV605 663802 - BD CD45 (HI30) BV605 663990 - BD CD56 (NCAM 16.2) BV605 665130 - BD CD196 (11A9) BV421 666651 - BD Horizon CD45RA (HI100) BV605 241116 - BD Francisella tularensis Antisera 335815 - BD CD79B FITC 340667 - BD CD34 (8G12) APC 340757 - BD Mouse IgG2a APC 346587 - BD Anti-Kappa PE 649454 - BD CD58 PE 655426 - BD CD10 (HI10A) APC-H7 656145 - BD CD11c PerCP-Cy5.5 (B-ly6) 659455 - BD CD19 SJ25C1 BV510 663193 - BD Anti-Lambda (1-155-2) APC 663803 - BD CD117 (104D2) BV605 663991 - BD CD64 (10.1) BV605 666652 - BD Horizon CD27 (M-T271) BV421 333949 - BD CD33 PE-Cy7 340655 - BD Anti-MPO FITC 340699 - BD CD7 (4H9) FITC 340717 - BD CD71 FITC 341636 - BD CD9 FITC 644494 - BD FMC7 V450 654975 - BD CD69 PE 659115 - BD Horizon CD7 APC-R700 (M-T701) 659459 - BD Mouse IgG1 X40 BV510 663980 - BD CD33 (P67.6) BV421 665119 - BD CD185 (RF8B2) APC 665134 - BD CD81 (JS-81) BV605 340707 - BD CD22 FITC 340738 - BD CD7 (M-T701) FITC 340928 - BD CD41A FITC 341103 - BD CD19 PE-Cy7 344636 - BD Zap70 (1E7.2) PE 647460 - BD CD14 V500-C 652359 - BD CD11c PE-Cy7 655154 - BD CD24 FITC 659451 - BD CD20 (L27) BV421 663799 - BD CD11c (B-Ly6) BV605 665127 - BD Ki-67 (B56) FITC 666648 - BD® CD26 (M-A261) APC 335817 - BD CD79B APC 340669 - BD CD34 (8G12) PE 340761 - BD Mouse IgG1 PE 340865 - BD CD19 (4G7) PerCP 347206 - BD CD138 RPE 348804 - BD CD19 APC-Cy7 655429 - BD CD27 PerCP-Cy5.5 656149 - BD CD23 FITC EBVCS-5 663195 - BD CD14 (MPhiP9) PE-Cy7 663979 - BD CD22 (HIB22) BV421 663994 - BD CD123 (9F5) APC-R700 666655 - BD Horizon CD25 (2A3) BV421 335804 - BD CD2 PE-Cy7 340656 - BD CD7 (M-T701) PE 340719 - BD CD19 (SJ25C1) FITC 341637 - BD CD9 PE 646852 - BD CD38 V450 654976 - BD CD62P PE 655431 - BD CD71 APC-H7 M-A712 659116 - BD Horizon CD23 APC-R700 (EBVCS-5) 659476 - BD CD4 (SK3) BV421 663981 - BD CD 34 (8G12) BV421 665135 - BD CD294 (BM16) BV605 340654 - BD CD79A PE 340685 - BD CD56 PE 340701 - BD CD2 PE 340918 - BD FMC7 FITC 340946 - BD CD235ab [GA-R2(HIR20] PE 341098 - BD Anti-Kappa APC 642922 - BD CD15 V450 649459 - BD CD45RO PE 657869 - BD CD200 APC-R700 659117 - BD Horizon CD25 APC-R700 (2A3) 664530 - BD CD8 (SK1) BV786 665121 - BD CD223 (T47-530) PerCP-Cy5.5 340675 - BD CD20 PerCP 340691 - BD Anti-HLA-DR APC 340871 - BD CD5 Biotin 340997 - BD CD103 PE 641407 - BD CD4 APC-H7 644138 - BD Anti-Kappa F(Ab')2 FITC 656157 - BD Anti-Lamda APC-H7 658287 - BD Anti-Kappa V450 (TB28-2 664521 - BD CD13 (L138) BV711 664535 - BD CD45 (HI30) BV786 333948 - BD CD14 APC-Cy7 340698 - BD CD10 (W8E7) FITC 340716 - BD CD61 PerCP 341031 - BD CD55 PE 341635 - BD CD30 PE 644492 - BD CD19 V450 654666 - BD CD62L PE 659114 - BD Horizon CD34 APC-R700 (8G12) 659458 - BD Anti-HLA-DR L243 BV510 665118 - BD CD183 (1C6/CXCR3) PE-Cy7 665133 - BD CD40 (5C3) BV605 338433 - BD CD16 (3G8) PerCP-Cy5.5 340671 - BD CD4 PerCP 340764 - BD Mouse IgG2a FITC 340867 - BD CD117 PE 340950 - BD CD19 (SJ25C1) PerCP-Cy5.5 347208 - BD Anti-TdT FITC 641402 - BD Anti-HLA-DR APC-H7 656152 - BD CD36 FITC CLB-IVC7 663541 - BD CD23 (EBVCS-5)PE-Cy7 663996 - BD CD64 (10.1) PerCP-Cy 5.5 666658 - BD Horizon CD103 (BER-ACT8) BV605 340693 - BD CD8 (SK1) PerCP 340879 - BD Anti-Her-2/Neu PE 341010 - BD CD25 PE 641409 - BD CD8 APC-H7 644386 - BD CD64 PE 653314 - BD CD38 APC-H7 656311 - BD CD22 PerCP-Cy5.5 (S-HCL-1) 659110 - BD Horizon CD3 APC-R700 (SK7) 664537 - BD Mouse IgG1 (X40) BV786 340694 - BD CD25 FITC 340880 - BD Anti-Her-2/Neu FITC 341023 - BD CD2 APC 341632 - BD Mpo PE 641410 - BD IgG1 APC-H7 644486 - BD CD2 V450 654663 - BD CD69 APC 659111 - BD Horizon CD10 APC-R700 (HI10a) 664538 - BD CD22 (S-HCL-1) PE-Cy7 340706 - BD CD57 FITC 340926 - BD CD38 FITC 341102 - BD CD10 (HI10A) PE-Cy7 341653 - BD CD4 PerCP-Cy5.5 643774 - BD Anti-Kappa FITC 647458 - BD CD8 V500-C 652356 - BD Horizon CD3 V450 (SK7) 655116 - BD Horizon CD56 V450 B159 659450 - BD CD14 (MPhiP9) BV421 663798 - BD CD8 (SK1) BV605 665126 - BD FoxP3 (236A/E7) PerCP-Cy5.5 335806 - BD CD16 (B73.1) PE-Cy7 340659 - BD CD8 APC 340721 - BD CD19 (SJ25C1) PerCP 340766 - BD Mouse IgG2a PE 341639 - BD CD9 PerCP-Cy5.5 347210 - BD Anti-TdT APC 655111 - BD CD8 V450 655433 - BD CD9 APC-H7 659478 - BD CD38 (HB7) BV421 663983 - BD CD 123 (9F5) BV421 665416 - BD CD27 (O323) BV510 666661 - BD Horizon Anti-Human IgM (G20-127) BV605 335811 - BD CD20 PE-Cy7 339203 - BD CD45 AmCyan 340663 - BD CD3 PerCP 340678 - BD CD33 FITC 340854 - BD CD4 Biotin 340934 - BD CD23 APC 348798 - BD Mouse IgG1 PE-Cy7 655734 - BD CD28 PERCP-Cy5.5 657699 - BD CD13 APC-R700 663189 - BD CD38 (HB7) BV605 663987 - BD CD15 (W6D3) BV605 664524 - BD CD56 (NCAM16.2) BV711 666665 - BD Horizon CD66c (B6.2/CD66) BV786 335812 - BD CD20 APC-Cy7 340708 - BD CD22 PE 340754 - BD Mouse IgG1 APC 341105 - BD CD4 APC-Cy7 344934 - BD Zap70 (1E7.2) FITC 647464 - BD CD20 V500-C 653312 - BD CD7 APC 655157 - BD CD27 PE-Cy7 659452 - BD CD56 (NCAM16.2) BV421 663190 - BD CD200 (MRC OX-104) BV605 663800 - BD CD13 (L138) BV605 665128 - BD CD30 (Ber-H8) BV421 666649 - BD® CD28 (L293) APC-H7 335805 - BD CD8 PE-Cy7 340658 - BD CD5 APC 340720 - BD CD19 (SJ25C1) PE 341638 - BD CD9 APC 347209 - BD Anti-TdT PE 647450 - BD CD45 V500-C 655019 - BD CD27 APC 655432 - BD CD79b PerCP-Cy5.5 SN8 659477 - BD CD19 (SJ25C1) BV421 663982 - BD CD 117 (104D2) BV421 665136 - BD CD366 (7D3) BV605 333947 - BD CD117 PerCP-Cy5.5 340697 - BD CD5 PE 340715 - BD CD61 FITC 341029 - BD CD71 APC 341634 - BD CD30 FITC 644490 - BD CD16 (3G8) V450 654665 - BD CD27 PE 659113 - BD Horizon CD33 APC-R700 (P67-6) 659457 - BD CD56 NCAM16.2 BV510 665117 - BD CD152 (BNI3) PE 665132 - BD CD5 (L17F12) BV510 335808 - BD CD38 PE-Cy7 339199 - BD CD8 AmCyan 340661 - BD CD3 APC 340723 - BD CD56 (NCAM16.2) FITC 340851 - BD CD3 Purified 340930 - BD CD41A PerCP-Cy5.5 341641 - BD CD1A PE 347212 - BD Mouse IgG1 PerCP-Cy5.5 655435 - BD B2-Microglobulin PerCP-Cy 5.5 659482 - BD CD45 2D1 BV510 663985 - BD CD5 (L17F12) BV605 666645 - BD® Anti-Human IgD (IA6-2) PerCP-Cy5.5 666663 - BD HorizonCD44 (L178) BV605 339197 - BD CD3 AmCyan 340673 - BD CD20 FITC 340690 - BD Anti-HLA-DR PerCP 340870 - BD CD5 Purified 340954 - BD CD20 PerCP-Cy5.5 641406 - BD CD3 APC-H7 656154 - BD CD81 APC-H7 658172 - BD CD123 APC (9F5) 663789 - BD Anti-HLA-DR (G46-6) BV421 664520 - BD CD10 (HI10a) BV711 664534 - BD CD23 (EBVCS-5) BV786 339205 - BD Anti-HLA-DR PerCP-Cy5.5 340664 - BD CD45 FITC 340679 - BD CD33 PE 340855 - BD CD8 (SK1) Purified 340936 - BD CD11B APC 348799 - BD CD4 PE-Cy7 642277 - BD IgG1 V450 655735 - BD CD200 PE-Cy7 657701 - BD CD64 APC-R700 663988 - BD CD 16 (3G8) BV605 664525 - BD CD123 (9F5) BV711 666666 - BD Horizon CD86 (2331/FUN-1) BV786 340686 - BD CD13 PE 340703 - BD CD15 FITC 340920 - BD CD10 (HI10A) PE 340948 - BD CD3 PerCP-Cy5.5 341099 - BD CD5 PerCP-Cy5.5 642924 - BD Anti-Lambda PE 647452 - BD IgG1 V500-C 649460 - BD CD45RO APC 657887 - BD CD56 APC-R700 659118 - BD Horizon CD38 APC-R700 (HB7) 664531 - BD CD16 (3G8) BV786 665123 - BD CD274 (MIH1) PE-Cy7 340688 - BD Anti-HLA-DR FITC 340704 - BD CD16 (NKP15) FITC 340922 - BD CD10 (HI10A) APC 341100 - BD CD3 APC-Cy7 643077 - BD CD14 APC-H7 647454 - BD CD3 V500-C 650660 - BD CD138 V500-C 658168 - BD CD9 V450 (M-L13) 659448 - BD CD3(SK7)BV421 663796 - BD CD1a (SK9) BV605 664532 - BD CD19 (SJ25C1) BV786 665124 - BD CD279 (MIH4) PE-Cy7 339206 - BD CD117 PE-Cy7 340665 - BD CD45 PerCP 340680 - BD CD33 APC 340857 - BD Anti-HLA-DR Purified 340883 - BD Anti-TCR-1 Alpha/Beta FITC 340938 - BD CD25 APC 348800 - BD CD5 PE-Cy7 642283 - BD CD20 V450 655933 - BD IFN GAMMA APC 657703 - BD CD79b APC-R700 663989 - BD CD 19 (SJ25C1) BV605 664526 - BD Mouse IgG1 (X40) BV711 667242 - BD® Anti TCR-C?1 (JOVI.1) PE 340705 - BD CD16 (B73.1) PE 340924 - BD CD10 (HI10A) FITC 341101 - BD CD3 PE-Cy7 643078 - BD CD19 APC-H7 647456 - BD CD4 V500-C 651850 - BD CD4 V450 655114 - BD CD14 V450 658170 - BD CD21 V450 (B-Ly4) 659449 - BD CD10(HI10a) BV421 663797 - BD CD7 (M-T701) BV605 665125 - BD FoxP3 (236A/E7) PE 340650 - BD Anti-Bcl-2 FITC 340682 - BD CD14 FITC 340858 - BD Anti-HLA-DR Biotin 340884 - BD Anti-TCR-1 Gamma/Delta Purified 340940 - BD CD20 APC 348801 - BD CD34 PE-Cy7 642284 - BD CD45 V450 649456 - BD CD26 FITC 656050 - BD CD38 PerCP-Cy5.5 657707 - BD TCR g/d-1 APC-R700 664527 - BD CD3 (SK7) BV786 667243 - BD® Anti TCR-C?1 (JOVI.1) APC-R700 340696 - BD CD5 FITC 340714 - BD CD11C APC 340882 - BD Anti-TCR-1 Alpha/Beta Purified 341026 - BD CD56 APC 341633 - BD CD79A PerCP-Cy5.5 644488 - BD CD5 V450 654664 - BD CD27 FITC 659112 - BD Horizon CD19 APC-R700 (SJ25C1) 665116 - BD CD42b (HIP1) PE 665131 - BD CD279 (MIH4) BV421 BD Trucount Tubes BD Multitest 6 color TBNK with or without Trucount Tubes BD FACS 7-Color Setup Beads BD FACS Loader BD FACSDiva Software BD FACSCanto System Software BD FACSCanto II Flow Cytometer FACS Loader BD Trucount Tubes BD FACSCount CD4 Reagents FACSCount CD4 Users Guide and Software BD Leucocount Reagent BD FACS Lyse Wash Assistant External Tank BD FACS Lyse Wash Assistant BD Tritest CD3/CD19/CD45 BD Trucount Tubes BD FACSCanto System Software BD FACSDiva Software BD FACS Sample Prep Assistant II BD FACSCount Control Kit BD FACSCount Reagent Kit BD FACSCount System Users Guide and Software BD FACSCount Instrument BD Simultest IMK-Lymphocyte BD Simultest CD3/CD4 BD Simultest CD3/CD19 BD Simultest CD3/CD8 BD Simultest CD3/CD16+56 BD Simultest IgG1/IgG2 BD Simultest Leucogate BD SimulSET Software BD FC Beads 7-Color Kit BD FACSLyric Flow Cytometer (4-2-2 optical configuration) BD FACSLyric Flow Cytometer (4-2 optical configuration) BD FACSLyric Flow Cytometer (4-3-3 optical configuration) BD Multitest 4-Color Assay Modules BD FACSuite Clinical Software BD Multitest 6-Color Assay Modules BD FACS Universal Loader BD FACSLyric Flow Cytometer (3-1 optical configuration) BD CS&T Beads BD FACSLyric Flow Cytometer (4-3-5 optical configuration) Anti-Cytokeratin BD Multitest 4-Color Assay Modules BD Multitest IMK Kit BD FACSLyric Flow Cytometer (4-2 optical configuration) BD CS&T Beads BD FACSLyric Flow Cytometer (4-3-3 optical configuration) BD Multitest CD3/CD8/CD45/CD4 BD FACSLyric Flow Cytometer (4-2-2 optical configuration) BD FACSuite Clinical Software BD FC Beads 7-Color Kit BD FACS Universal Loader BD FACSLyric Flow Cytometer (4-3-5 optical configuration) BD Multitest 6-Color Assay Modules BD FACSLyric Flow Cytometer (3-1 optical configuration) BD Trucount Tubes BD Multitest CD3/CD16+56/CD45/CD19 BD TrucountTubes BD Tritest CD3/CD16+CD56/CD45 BD Leucocount Combo Control BD Multi-Check CD4 Low Control BD Retic-Count Control BD Trucount Control Beads BD Multi-Check Control BD Leucocount RBC Control BD Leucocount PLT Control BD Multitest IMK kit BD Multitest CD3/CD8/CD45/CD4 BD Multitest CD3/CD16+56/CD45/CD19 BD Trucount Tubes BD Multiset Software BD CD3 (SK7) FITC (AKA Anti-Leu-4 FITC) BD FACSPresto CD4/Hb Cartridge BD FACSPresto System BD FACSPresto CD4/Hb Cartridge Kit BD FACSVia System BD CS&T Beads BD FACSVia clinical software BD Leucocount Kit BD Tritest CD3/CD4/CD45 BD Stem Cell Control BD FACSCanto Clinical Software with BD SCE Module BD SCE Template for BD CellQuest or BD CellQuest Pro BD Stem Cell Enumeration Kit BD Simultest IMK Plus BD Simultest CD4/CD8 BD Simultest CD3/HLA-DR BD Simulset Software Procount Software

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GKZ	Counter, Differential Cell	Hematology	Class 2	864.5220	2009-07-02
GKZ	Counter, Differential Cell	Hematology	Class 2	864.5220	2013-06-28
GKZ	Counter, Differential Cell	Hematology	Class 2	864.5220	2009-07-02
GKZ	Counter, Differential Cell	Hematology	Class 2	864.5220	2009-07-10
OYE	Flow Cytometric Reagents And Accessories.	Hematology	Class 2	864.5220	2015-05-01
GKZ	Counter, Differential Cell	Hematology	Class 2	864.5220	2009-07-02
GKZ	Counter, Differential Cell	Hematology	Class 2	864.5220	2009-07-02
MVU	Reagents, Specific, Analyte	Pathology	Class 1	864.4020	2007-04-06
GKZ	Counter, Differential Cell	Hematology	Class 2	864.5220	2010-07-06
GKZ	Counter, Differential Cell	Hematology	Class 2	864.5220	2009-07-01
GKZ	Counter, Differential Cell	Hematology	Class 2	864.5220	2009-07-01
GKZ	Counter, Differential Cell	Hematology	Class 2	864.5220	2014-04-10
GKZ	Counter, Differential Cell	Hematology	Class 2	864.5220	2009-07-06
GKZ	Counter, Differential Cell	Hematology	Class 2	864.5220	2009-07-01
GKZ	Counter, Differential Cell	Hematology	Class 2	864.5220	2009-07-07
JQW	Station, Pipetting And Diluting, For Clinical Use	Clinical Chemistry	Class 1	862.2750	2006-06-06
GKZ	Counter, Differential Cell	Hematology	Class 2	864.5220	2009-07-02
GKZ	Counter, Differential Cell	Hematology	Class 2	864.5220	2019-08-02
PER	Automated Pipetting, Diluting And Specimen Processing Workstations For Flow Cytometric Analysis	Clinical Chemistry	Class 1	862.2750	2010-07-06
GKZ	Counter, Differential Cell	Hematology	Class 2	864.5220	2009-07-07
GKZ	Counter, Differential Cell	Hematology	Class 2	864.5220	2009-07-10
OYE	Flow Cytometric Reagents And Accessories.	Hematology	Class 2	864.5220	2020-10-12
LYE	Cytokeratins	Immunology	Class 2	866.5550	2009-07-06
OYE	Flow Cytometric Reagents And Accessories.	Hematology	Class 2	864.5220	2017-07-17
GKZ	Counter, Differential Cell	Hematology	Class 2	864.5220	2009-07-02
JPK	Mixture, Hematology Quality Control	Hematology	Class 2	864.8625	2018-01-04
GKZ	Counter, Differential Cell	Hematology	Class 2	864.5220	2010-07-06
GKZ	Counter, Differential Cell	Hematology	Class 2	864.5220	2009-07-10
LIZ	Assay, T Lymphocyte Surface Marker	Hematology	Class 2	864.5220	2009-07-06
OYE	Flow Cytometric Reagents And Accessories.	Hematology	Class 2	864.5220	2015-12-22
JPK	Mixture, Hematology Quality Control	Hematology	Class 2	864.8625	2015-12-22
GKL	Counter, Cell, Automated (Particle Counter)	Hematology	Class 2	864.5200	2015-12-22
PMG	Automated Multicolor Fluorescent Imaging Cytometric Analysis System	Hematology	Class 2	864.5220	2015-12-22
OYE	Flow Cytometric Reagents And Accessories.	Hematology	Class 2	864.5220	2016-11-01
GKZ	Counter, Differential Cell	Hematology	Class 2	864.5220	2009-07-01
GGL	Control, White-Cell	Hematology	Class 2	864.8625	2021-03-09
GKZ	Counter, Differential Cell	Hematology	Class 2	864.5220	2011-12-12
GKZ	Counter, Differential Cell	Hematology	Class 2	864.5220	2009-07-10
GKZ	Counter, Differential Cell	Hematology	Class 2	864.5220	2015-12-22

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Becton Dickinson and Company

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
9680577	BECTON DICKINSON GMBH	HEIDELBERG Baden-Wurttemberg, DE
3003916417	BECTON DICKINSON IND. CIRURGICAS LTDA.	CURITIBA Parana, BR
3036495171	BD Biosciences San Diego	San Diego, CA, US
3015292643	BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES	San Diego, CA, US
3010141591	BD Kiestra B.V.	Drachten Fryslan, NL

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K910283	Danam Electronics	DANAM DATACELL-18	1991-04-12
K102064	Becton, Dickinson & CO	BD FACS SAMPLE PREP ASSISTANT III (SPA III)	2011-03-07
K851403	Ventrex Laboratories, Inc.	VENTREZYME ALLERGEN DATA REDUCTION SYSTEM	1985-06-21
K761290	Nuclear Medical Laboratories, Inc.	COMPU-PET 300	1977-02-24
K770210	G.D. Searle and Co.	ANALYTIX AUTO SAMPLE PREP. STA. 1600	1977-02-14

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0009-2025	Becton, Dickinson and Company, BD Bio Sciences	1	BD FACSDuet Premium Sample Preparation System, REF: 666340, 666339; and BD FACSDuet Sample Preparation System (Base), REF: 663128, 662588, used with software V 1.4.1. Intended use: to prepare human specimens to be analyzed.
Z-0022-2009	Becton Dickinson and Company	1	BD Visitec High Viscosity Injector, 4mm Ref: 585173. The product is intended for Vitroretinal Surgery.
Z-0002-05	ABX Diagnostics Inc	2	Automated Differential Cell Counter
Z-0003-05	ABX Diagnostics Inc	2	Automated Differential Cell Counter
Z-0011-2014	Siemens Healthcare Diagnostics	2	ADVIA 2120/2120i Hematology Systems with ADVIA Autoslide connected to it, SMN 10361162 and SMN 10361798 --- CLASSIFICATION NAME: Counter, Differential Cell, Automated (Particle Counter) The ADVIA 2120/2120i are hematology systems that utilizes the principles of flow cytometry in order to provide complete blood counts.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3027394506. Last updated year: 2026. Please use registration number 3027394506 when referencing this establishment in official correspondence.