44 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: Class Ii
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BD FACS 7-color Setup beads BD Biosciences, San Jose, CA 95131. BD FACS 7 color Setup Beads are for in vitro diagnostic use on BD FACSCanto or BD FACSCanto II systems. The beads are run with BD FACSCanto clinical software. This system provides application specific setup, including automated compensation and cytometer quality control (QC) with minimal user intervention.
FDA Enforcement
Class II
·Terminated·BD Biosciences, Systems & Reagents·September 26, 2012
BD FACS Canto and associated Fluidics Cart Product Usage: Flow cytometer for use in In vitro Diagnostics.
FDA Enforcement
Class II
·Terminated·BD Biosciences, Systems & Reagents·July 9, 2014
Anti EpCam PE - Analyte Specific Reagent. Anti-EpCAM is directed against human epithelial adhesion molecule that has been identified as a 40 -kilodalton (kd) protein in Western Blotting.
FDA Enforcement
Class II
·Terminated·BD Biosciences, Systems & Reagents·May 7, 2014
BD FACSCalibur; Catalog Numbers 342973, 342975, 34976 In vitro Diagnostics Use.
FDA Enforcement
Class II
·Terminated·BD Biosciences, Systems & Reagents·April 8, 2015
CD123 (9F5) PE Catalog number 649453 Analyte Specific Reagent
FDA Enforcement
Class II
·Terminated·BD Biosciences, Systems & Reagents·April 8, 2015
CD8 (Leu-2a) PE (In vitro diagnostic), Catalog number 340046. Hematology: Single color direct immunofluorescence reagent for enumerating percentages of mature human suppressor/cytotoxic (CD8+) lymphocytes in erythrocyte-lysed whole blood or peripheral blood mononuclear cell suspensions.
FDA Enforcement
Class II
·Terminated·BD Biosciences, Systems & Reagents·January 28, 2015
Anti-Lambda APC-H7, Catalog Number 656157. Product Usage: Intended for in vitro flow cytometric immunophenotyping of hematologic disorders.
FDA Enforcement
Class II
·Terminated·BD Biosciences, Systems & Reagents·January 28, 2015
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 BD Trucount Tubes IVD, REF: 662995. BD Multitest" 6-Color TBNK reagent with optional BD Trucount" Tubes is a six-color direct immunofluorescence reagent.
FDA Enforcement
Class II
·Ongoing·Becton, Dickinson and Company, BD Biosciences·July 24, 2024
CD11b APC: ASR, REF: 340936, and CE, REF: 333143
FDA Enforcement
Class II
·Ongoing·Becton, Dickinson and Company, BD Biosciences·January 17, 2024
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 staining pattern.
FDA Enforcement
Class II
·Terminated·Becton, Dickinson and Company, BD Biosciences·December 2, 2015
BD Trucount Tubes: Catalog number: 340334 Hematology: BD Trucount tubes are used for determining absolute counts of leucocytes in blood.
FDA Enforcement
Class II
·Terminated·Becton, Dickinson and Company, BD Biosciences·July 27, 2016
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 cells.
FDA Enforcement
Class II
·Terminated·Becton, Dickinson and Company, BD Biosciences·September 2, 2015
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) antigen receptors are composed of a non-covalently associated complex of Ig and two other proteins, Iga and Igb, which have been designated as CD79a and CD79b, respectively. antigen
FDA Enforcement
Class II
·Terminated·Becton, Dickinson and Company, BD Biosciences·October 26, 2016
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 diagnostic products such as BD Tritest reagents, and a suitably equipped flow cytometer. BD Trucount tubes can be used with the BD FACS Loader.
FDA Enforcement
Class II
·Terminated·Becton, Dickinson and Company, BD Biosciences·May 4, 2016
BD FACSLyric Flow Cytometer, 3-Laser 8 Color Instrument, REF: 654587, when using BD Trucount Tubes
FDA Enforcement
Class II
·Terminated·Becton, Dickinson and Company, BD Biosciences·October 16, 2019
BD FACSLyric Flow Cytometer, 3-Laser 8 Color Instrument, REF: 662877, when using BD Trucount Tubes
FDA Enforcement
Class II
·Terminated·Becton, Dickinson and Company, BD Biosciences·October 16, 2019
BD FACSLyric Flow Cytometer, 3-Laser 10 Color Instrument, REF: 662878, and 66287808 when using BD Trucount Tubes
FDA Enforcement
Class II
·Terminated·Becton, Dickinson and Company, BD Biosciences·October 16, 2019
BD FACSLyric Flow Cytometer, 2-Laser 6 Color Instrument, REF: 662876, when using BD Trucount Tubes
FDA Enforcement
Class II
·Terminated·Becton, Dickinson and Company, BD Biosciences·October 16, 2019
BD FACSLyric Flow Cytometer,3-Laser 10 Color Instrument, REF: 659180 and 65918001, when using BD Trucount Tubes
FDA Enforcement
Class II
·Terminated·Becton, Dickinson and Company, BD Biosciences·October 16, 2019
BD FACSLyric Flow Cytometer, 3-Laser 12 Color Instrument, REF: 663029, when using BD Trucount Tubes
FDA Enforcement
Class II
·Terminated·Becton, Dickinson and Company, BD Biosciences·October 16, 2019