Company
Becton, Dickinson and Company, BD Biosciences
FDA 510(k) clearances and medical device recalls filed under this name. Name variants (Inc, Corp, punctuation) are merged.
0510(k) clearances (0 in 12 months)
35recalls (0 in 12 months)
25recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| OYE | Flow Cytometric Reagents And Accessories. | 12 |
| MVU | Reagents, Specific, Analyte | 10 |
| GKZ | Counter, Differential Cell | 7 |
| PER | Automated Pipetting, Diluting And Specimen Processing Workstations For Flow Cytometric Analysis | 3 |
| GKL | Counter, Cell, Automated (Particle Counter) | 1 |
| JPK | Mixture, Hematology Quality Control | 1 |
| LIZ | Assay, T Lymphocyte Surface Marker | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| No clearances in this window. | |||
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 12, 2024 | Becton, Dickinson and Company, BD Biosciences BD Multitest 6-Color TBNK CE-IVD, REF: 644611;
BD Multitest 6-Color TBNK Kit with BD Trucount Tubes CE-IVD, REF: 337166;
BD Multitest 6-Color TBNK, IVD, REF: 662967;
BD Multitest 6-Color TBNK Kit with Open, Classified |
OYE | K170974 |
| Jan 5, 2024 | Becton, Dickinson and Company, BD Biosciences CD11b APC: ASR, REF: 340936, and CE, REF: 333143 Open, Classified |
MVU | None listed |
| Nov 3, 2022 | Becton, Dickinson and Company, BD Biosciences BD Multitest 6-Color TBNK with optional BD Trucount Tubes (Cat. No. 662995), for use with BD FACSLyric, BD FACSCanto II, and BD FACSCanto flow cytometers to determine the percentages and absolute coun Open, Classified |
GKZ | K090967 |
| Nov 3, 2022 | Becton, Dickinson and Company, BD Biosciences BD Trucount Tubes (Cat. No. 663028), used for determining absolute counts of leukocytes in blood. BD Trucount Tubes are designed for use with in vitro diagnostic products such as BD Tritest reagents, Open, Classified |
GKZ | K090967 |
| Nov 3, 2022 | Becton, Dickinson and Company, BD Biosciences BD Trucount Tubes (Cat. No. 340334), used for determining absolute counts of leucocytes in blood. BD Trucount tubes are designed for use with in vitro diagnostic products such as BD Tritest reagents, Open, Classified |
GKZ | K090967 |
| Mar 25, 2022 | Becton, Dickinson and Company, BD Biosciences BD Anti-Kappa PE (Cat. No. 346587) is an analyte specific reagent for the Anti-Kappa antibody, which specifically recognizes the kappa light chains of human immunoglobulins. Anti-Kappa is used for in Open, Classified |
MVU | None listed |
| Mar 25, 2022 | Becton, Dickinson and Company, BD Biosciences BD Anti-Kappa APC (Cat. No. 341098) is an analyte specific reagent for the Anti-Kappa antibody, which specifically recognizes the kappa light chains of human immunoglobulins. Anti-Kappa is used for in Open, Classified |
MVU | None listed |
| Jul 22, 2021 | Becton, Dickinson and Company, BD Biosciences BD" Mouse IgG2a Isotype Control APC X39 ASR Terminated |
MVU | None listed |
| Oct 5, 2020 | Becton, Dickinson and Company, BD Biosciences BD" Multi-Check CD4 Low Control 2.5 mL IVD - Product Usage: intended as a complete process control for immunophenotyping by flow cytometry. Terminated |
JPK | K150815 |
| May 13, 2020 | Becton, Dickinson and Company, BD Biosciences Analyte specific reagent. REF/UDI: 641408/641408-4012-1-1 (US); 641417/641417-1157-1-01 (OUS); 641399/641399-4012-1-01 (US Research Use Only) - Product Usage: CD45 is intended for in vitro diagnostic Terminated |
MVU | None listed |
| Aug 19, 2019 | Becton, Dickinson and Company, BD Biosciences BD FACSLyric Flow Cytometer, 3-Laser 12 Color Instrument, REF: 663029, when using BD Trucount Tubes Terminated |
OYE | K170974 |
| Aug 19, 2019 | Becton, Dickinson and Company, BD Biosciences BD FACSLyric Flow Cytometer,3-Laser 10 Color Instrument, REF: 659180 and 65918001, when using BD Trucount Tubes Terminated |
OYE | K170974 |
| Aug 19, 2019 | Becton, Dickinson and Company, BD Biosciences BD FACSLyric Flow Cytometer, 3-Laser 8 Color Instrument, REF: 654587, when using BD Trucount Tubes Terminated |
OYE | K170974 |
| Aug 19, 2019 | Becton, Dickinson and Company, BD Biosciences BD FACSLyric Flow Cytometer, 2-Laser 6 Color Instrument, REF: 651165, when using BD Trucount Tubes Terminated |
OYE | K170974 |
| Aug 19, 2019 | Becton, Dickinson and Company, BD Biosciences BD FACSLyric Flow Cytometer, 2-Laser 4 Color Instrument, REF: 651164, when using BD Trucount Tubes Terminated |
OYE | K170974 |
| Aug 19, 2019 | Becton, Dickinson and Company, BD Biosciences BD FACSLyric Flow Cytometer, 3-Laser 10 Color Instrument, REF: 662878, and 66287808 when using BD Trucount Tubes Terminated |
OYE | K170974 |
| Aug 19, 2019 | Becton, Dickinson and Company, BD Biosciences BD FACSLyric Flow Cytometer, 3-Laser 8 Color Instrument, REF: 662877, when using BD Trucount Tubes Terminated |
OYE | K170974 |
| Aug 19, 2019 | Becton, Dickinson and Company, BD Biosciences BD FACSLyric Flow Cytometer, 2-Laser 6 Color Instrument, REF: 662876, when using BD Trucount Tubes Terminated |
OYE | K170974 |
| Aug 19, 2019 | Becton, Dickinson and Company, BD Biosciences BD FACSLyric Flow Cytometer, 2-Laser 4 Color Instrument, REF: 662875, when using BD Trucount Tubes Terminated |
OYE | K170974 |
| Jul 8, 2019 | Becton, Dickinson and Company, BD Biosciences BD FACS Sample Prep Assistant (SPA) III - Product Usage: Prep Assistant III is intended to prepare human whole blood for flow cytometric analysis on BD FACSCanto II and BD FACSCalibur flow cytometry s Terminated |
PER | K131301 |
| Jul 8, 2019 | Becton, Dickinson and Company, BD Biosciences BD FACS Sample Prep Assistant (SPA) II Upgrade - Product Usage: K050191: The BD FACSCanto system with BD FACSCanto clinical software when used with the BD FACS Sample Prep Assistant II /III is intende Terminated |
PER | K050191 |
| Jul 8, 2019 | Becton, Dickinson and Company, BD Biosciences BD FACS Sample Prep Assistant (SPA) II - Product Usage: K050191: The BD FACSCanto system with BD FACSCanto clinical software when used with the BD FACS Sample Prep Assistant II /III is intended for us Terminated |
PER | K050191 |
| Feb 1, 2019 | Becton, Dickinson and Company, BD Biosciences BD FACSLyric 3L 10C with FACSuite Clinical Software v1.1.1, catalog number 662878
BD FACSLyric is a high-performance flow cytometer designed to support both routine clinical analysis and research for Terminated |
OYE | K170974 |
| Jul 13, 2018 | Becton, Dickinson and Company, BD Biosciences BD FACS Universal Loader (Optional) to the BD FACSLyric Clinical System, Model 662879 (Universal Loader), Rx Only. The firm name on the label is Becton, Dickinson and Company, BD Biosciences, San Jos Terminated |
OYE | K170974 |
| Sep 21, 2016 | Becton, Dickinson and Company, BD Biosciences CD79b PE (ASR) , Catalog number 335816 ;
Hematology:
The CD79b antibody recognizes an epitope on the extracellular domain of a 3640 kilodalton (kDa) type I membrane glycoprotein. Immunoglobulin (Ig) Terminated |
MVU | None listed |
| Aug 9, 2016 | Becton, Dickinson and Company, BD Biosciences BD Tritest CD3 FITC/CD4 PE/CD45 PerCP (IVD);
Catalog number 340383.
Label states: Contains CD3 FITC/CD4 PE/CD45 per CP with Gelatin and 0.1% sodium azide.
Hematology:
BD Tritest CD3 fluorescein isot Terminated |
GKZ | K071143 |
| Jun 24, 2016 | Becton, Dickinson and Company, BD Biosciences BD Trucount Tubes:
Catalog number: 340334
Hematology: BD Trucount tubes are used for determining absolute counts of leucocytes in blood. Terminated |
GKZ | K970836 |
| Mar 31, 2016 | Becton, Dickinson and Company, BD Biosciences BD Trucount Absolute Counting Tubes:
Model number: 340334
IVD;
BD Trucount tubes are used for determining absolute counts of leucocytes in blood. BD Trucount tubes are designed for use with in vitro Terminated |
GKZ | K970836 |
| Mar 18, 2016 | Becton, Dickinson and Company, BD Biosciences BD-Retic-Count Reticulocyte Reagent System;
Hematology: Used for in vitro diagnostics Terminated |
GKL | K880636 |
| Jan 25, 2016 | Becton, Dickinson and Company, BD Biosciences BD FMC7 FITC: Model 430918.
FMC7 is intended for in vitro diagnostic use in the identification of cells expressing FMC7 antigen.
Product Usage:
Analyte Specific Reagent. FMC7 is intended for in vitro Terminated |
MVU | None listed |
| Jan 11, 2016 | Becton, Dickinson and Company, BD Biosciences FMC7 FITC, Catalog No. 340918 Analyte Specific Reagent. Terminated |
MVU | None listed |
| Oct 30, 2015 | Becton, Dickinson and Company, BD Biosciences BD CD64 APC-R700;
Analyte Specific Reagent; Model 657701; Lot No. 4344945, 5037611 and 5063945.
Hematology - used as analyte specific reagent - contamination leads to possibility of unexpected stain Terminated |
MVU | None listed |
| Sep 30, 2015 | Becton, Dickinson and Company, BD Biosciences BD CD3 (SK7) FITC; IVD; Catalog # 349201 and 340542
Hematology: The CD3 antibody reacts with the epsilon chain of the CD3 antigen/T-cell antigen receptor (TCR) complex. In vitro diagnostic. Terminated |
LIZ | K842218 |
| Sep 24, 2015 | Becton, Dickinson and Company, BD Biosciences CD4 (SK3), FITC;
Contains CD4 FITC with gelatin and 0.1% sodium Azide.
Catalog number 340133
in vitro diagnostic used in Hematology: The SK3 monoclonal antibody reacts with human CD4, a 59-kDa cell s Terminated |
GKZ | K900802 |
| Aug 24, 2015 | Becton, Dickinson and Company, BD Biosciences BD CD56 PE Cy 7: NCAM16.2 ASR
Analyte Specific Reagent, Catalog number 335809
Hematology:
The CD 56 antigen promotes homophilic adhesion in neurons and may be involved in homophilic adhesion of NK ce Terminated |
MVU | None listed |