Data / Medical devices / United States / Becton, Dickinson and Company, BD Biosciences
Becton, Dickinson and Company, BD Biosciences: FDA-registered device maker in Milpitas, CA, United States, 35 510(k) clearances
Becton, Dickinson and Company, BD Biosciences is registered with the FDA (registration 3027394506) in Milpitas, CA, United States. It lists 15 device types. The FDA files 35 510(k) clearances under its listings, the newest dated September 28, 2020. 4 recall events name it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3027394506
- Address
- 155 North McCarthy Boulevard, Milpitas, CA, United States, 95035
- Owner or operator
- Becton Dickinson and Company (9922032)
- Roles
- Complaint file establishment, Manufacturer, Specification developer
- First device listed
- November 17, 1992
- Registered through
- 2027
- Brand names listed
- 241115 - BD Francisella tularensis Antigen, 241116 - BD Francisella tularensis Antisera, 333947 - BD CD117 PerCP-Cy5.5, 333948 - BD CD14 APC-Cy7, 333949 - BD CD33 PE-Cy7, 335804 - BD CD2 PE-Cy7, 335805 - BD CD8 PE-Cy7, 335806 - BD CD16 (B73.1) PE-Cy7 and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Assay, B Lymphocyte Marker | LJD | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Assay, T Lymphocyte Surface Marker | LIZ | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Automated Multicolor Fluorescent Imaging Cytometric Analysis System | PMG | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Automated Pipetting, Diluting And Specimen Processing Workstations For Flow Cytometric Analysis | PER | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Control, White-Cell | GGL | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Counter, Cell, Automated (Particle Counter) | GKL | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Counter, Differential Cell | GKZ | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Cytokeratins | LYE | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Flow Cytometric Reagents And Accessories. | OYE | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| General Purpose Reagent | PPM | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Mixture, Hematology Quality Control | JPK | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Products, Red-Cell Lysing Products | GGK | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Reagents, Specific, Analyte | MVU | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Station, Pipetting And Diluting, For Clinical Use | JQW | 1 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Test, Qualitative, For Hla, Non-Diagnostic | MZI | U | Complaint file establishment, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| September 28, 2020 | K201814 | BD 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 Kit | OYE | Substantially Equivalent | Becton, Dickinson and Company | accessdata.fda.gov |
| July 3, 2017 | K170974 | BD 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 TBNK | OYE | Substantially Equivalent | Becton, Dickinson and Company | accessdata.fda.gov |
| December 17, 2015 | K150815 | BD FACSPresto System, BD FACSPresto CD4/Hb Cartridge, BD FACSPresto CD4/Hb Cartridge Kit | PMG | Substantially Equivalent | Becton, Dickinson and Company | accessdata.fda.gov |
| February 27, 2015 | K141468 | BD FACSCanto II flow cytometer (4-2-2 and 5-3 configurations), BD FACSCanto flow cytometer (4-3-3 configuration) | OYE | Substantially Equivalent | Bd Biosciences | accessdata.fda.gov |
| August 2, 2013 | K131301 | BD FACS SAMPLE PREP ASSISTANT III | PER | Substantially Equivalent | Becton, Dickinson & CO | accessdata.fda.gov |
| July 31, 2009 | K090967 | BD MULTITEST 6-COLOR TBNK REAGENT, MODEL 644611 | GKZ | Substantially Equivalent | Bd Biosciences | accessdata.fda.gov |
| August 14, 2008 | K081213 | BD FACSCOUNT CD4 REAGENTS WITH MODEL 339010 | GKZ | Substantially Equivalent | Bd Biosciences | accessdata.fda.gov |
| June 6, 2007 | K071143 | BD TRITEST CD3/CD4/CD45, MODEL 340383 | GKZ | Substantially Equivalent | Bd Biosciences | accessdata.fda.gov |
| September 14, 2006 | K062087 | BD FACSCANTO II FLOW CYTOMETER, MODEL 338960; (5-3), MODEL 339473; (4-2-2), MODEL 338962 | GKZ | Substantially Equivalent | Bd Biosciences | accessdata.fda.gov |
| February 22, 2005 | K050191 | MODIFICATION TO BD FACSCANTO SYSTEM WITH BD FACSCANTO CLINICAL SOFTWARE | PER | Substantially Equivalent | Becton, Dickinson & CO | accessdata.fda.gov |
| September 10, 2004 | K040725 | BD FACSCANTO SYSTEM | GKZ | Substantially Equivalent | Becton Dickinson Immunocytometry Systems | accessdata.fda.gov |
| September 10, 2004 | K040026 | BD FACS 7-COLOR SETUP BEADS | GKZ | Substantially Equivalent | Becton Dickinson Immunocytometry Systems | accessdata.fda.gov |
| June 6, 2001 | K010953 | CELL-DYN 4000 IMMUNO T-CELL (CD3/4/8) ASSAY | GKZ | Substantially Equivalent | Abbott Laboratories | accessdata.fda.gov |
| May 5, 2000 | K000897 | CALIBRITE PERCP-CY5.5 BEADS AND FACSCOMP SOFTWARE | GKZ | Substantially Equivalent | Bd Biosciences | accessdata.fda.gov |
| June 29, 1998 | K981342 | ABBOTT CELL-DYN 4000 IMMUNOPIT (CD61) ASSAY | GKZ | Substantially Equivalent | Abbott Laboratories | accessdata.fda.gov |
| May 22, 1998 | K980858 | MULTITEST CD3/CD16+56/CD45/CD19 REAGENT AND MULTITEST IMK KIT LYSING SOLUTION | GKZ | Substantially Equivalent | Becton Dickinson Immunocytometry Systems | accessdata.fda.gov |
| February 17, 1998 | K973483 | FACSCOMP SOFTWARE AND CALIBRITE BEADS FOR USE IN FLOW CYTOMETER INSTRUMENT SET | GKZ | Substantially Equivalent | Becton Dickinson Immunocytometry Systems | accessdata.fda.gov |
| December 1, 1997 | K971205 | TRI TEST REAGENT CD4 FIT C/CD8 PE/CD3 PERCP WITH TRUCOUNT ABSOLUTE COUNT TUBES | GKZ | Substantially Equivalent | Becton Dickinson Immunocytometry Systems | accessdata.fda.gov |
| November 25, 1997 | K971110 | TRITEST REAGENT CD3 FITC/CD16+CD56 PE/CD45 PERCP;WITH TRUCOUNT ABSOLUTE COUNT TUBES | GKZ | Substantially Equivalent | Becton Dickinson Immunocytometry Systems | accessdata.fda.gov |
| November 21, 1997 | K970326 | TRITEST REAGENT CD3 FITC/CD8 PE/CD45 PERCP;WITH TRUCOUNT ABSOLUTE COUNT TUBES | GKZ | Substantially Equivalent | Becton Dickinson Immunocytometry Systems | accessdata.fda.gov |
| October 22, 1997 | K970742 | TRITEST CD3 FITC/CD19 PE/CD45 PERCP REAGENT WITH TRUCOUNT ABSOLUTE COUNT TUBES | GKZ | Substantially Equivalent | Becton Dickinson Immunocytometry Systems | accessdata.fda.gov |
| August 26, 1997 | K970836 | TRUCOUNT ABSOLUTE COUNT TUBES/COUNTING CONTROL BEADS | GKZ | Substantially Equivalent | Becton Dickinson Immunocytometry Systems | accessdata.fda.gov |
| December 12, 1996 | K963963 | MULTISET SOFTWARE FOR AUTOMATED FLOW CYTOMETRIC DATA ANALYSIS | GKZ | Substantially Equivalent | Becton Dickinson Immunocytometry Systems | accessdata.fda.gov |
| November 20, 1995 | K953302 | FACS LOADER SYSTEM | GKZ | Substantially Equivalent | Becton Dickinson Immunocytometry Systems | accessdata.fda.gov |
| August 22, 1995 | K950057 | TRITEST CONTROL REAGENT IGG1 FITC/IGFG1 PE/CD45 PERCP | GKZ | Substantially Equivalent | Becton Dickinson Immunocytometry Systems | accessdata.fda.gov |
| September 9, 1994 | K933486 | FASCOUNT SYSTME | GKZ | Substantially Equivalent | Becton Dickinson Immunocytometry Systems | accessdata.fda.gov |
| August 5, 1993 | K924587 | SIMULTEST CD3/ANTI-HLA-DR | GKZ | Substantially Equivalent | Becton Dickinson Immunocytometry Systems | accessdata.fda.gov |
| February 6, 1992 | K913192 | SIMULTEST(TM) IMK-LYMPHOCYTE | GKZ | Substantially Equivalent | Bd Becton Dickinson Vacutainer Systems Preanalytic | accessdata.fda.gov |
| December 17, 1990 | K904390 | ANTI-HUMAN LEU-2A (CD8) PE | GKZ | Substantially Equivalent | Bd Becton Dickinson Vacutainer Systems Preanalytic | accessdata.fda.gov |
| May 15, 1990 | K900802 | ANTI-HUMAN LEU-3A (CD4) FITC | GKZ | Substantially Equivalent | Bd Becton Dickinson Vacutainer Systems Preanalytic | accessdata.fda.gov |
| April 2, 1990 | K900078 | SIMULTEST IMK PLUS(TM) | GKZ | Substantially Equivalent | Bd Becton Dickinson Vacutainer Systems Preanalytic | accessdata.fda.gov |
| July 7, 1988 | K864893 | ANTI-CYTOKERATIN MONOCLONAL ANTIBODY | LYE | Substantially Equivalent | Bd Becton Dickinson Vacutainer Systems Preanalytic | accessdata.fda.gov |
| March 21, 1988 | K880636 | RETICCOUNT SOFTWARE | GKL | Substantially Equivalent | Bd Becton Dickinson Vacutainer Systems Preanalytic | accessdata.fda.gov |
| July 2, 1986 | K851639 | ANTI-LEU-12 B CELL REAGENT | LJD | Substantially Equivalent | Bd Becton Dickinson Vacutainer Systems Preanalytic | accessdata.fda.gov |
| December 27, 1984 | K842218 | ANTI-LEU-4 FITC LYSIN C BUFFER | LIZ | Substantially Equivalent | Bd Becton Dickinson Vacutainer Systems Preanalytic | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| July 8, 2025 | 97141 | Class II | Ongoing | BD Trucount Controls, 30 Test - REF: 664343, RxOnly, IVD | Control kits contain incorrect standard deviation (SD) values for the low and high control beads which compromises the accurate calculation of bead counts. | accessdata.fda.gov |
| June 3, 2025 | 96922 | Class II | Ongoing | REF: 335775, BD FACS, 7-Color Setup Beads, 25 setups per kit, Rx Only, IVD. Used in flow cytometry for fluorescence compensation. | Due to customer complaints, errors in spectral overlap factors table for 7-color setup beads may affect accurate setup of the flow cytometry instrument prior to analyzing samples. | accessdata.fda.gov |
| November 1, 2024 | 95729 | Class II | Ongoing | FACSLyric 2L4C Instrument US, Catalog Number 662875, UDI 00382906628756 BD FACSLyric" flow cytometer is intended for in vitro diagnostic for the following: " Immunophenotyping using up to six fluorescence detection chann | On October 18, 2024, BD has identified through customer complaints and an increase in field failures / replacements of the power supply module (part number 650781, Power Module AC-DC 250W 12/24V M3S4S6) on BD FACSLyric flow cytometers, which has the potential for the instruments to fail to power on and/or stay on. The potential power supply failure on BD FAC | accessdata.fda.gov |
| August 12, 2024 | 95215 | Class II | Ongoing | 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 analyz | Sample preparation system with software may cause: 1) Multidispense feature enabled with 2-tube assay: Specimen volume dispensed into tube1 at least 3% higher than volume in tube2, or 2) Absolute counts calculated using Trucount Tubes: increased volume in tube1 may result in 20% higher absolute counts in tube 1 than tube 2; could result in additional blood c | accessdata.fda.gov |
Compare with other makers
- All makers of Automated Pipetting, Diluting And Specimen Processing Workstations For Flow Cytometric Analysis
- All makers of Counter, Differential Cell
- All makers of General Purpose Reagent
- All makers of Flow Cytometric Reagents And Accessories.
- All makers of Control, White-Cell
- All makers of Station, Pipetting And Diluting, For Clinical Use
Updated August 1, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.