9 results
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82ms
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Sources: EU EUDAMED, US FDA
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FDA Enforcement
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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 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 FACSCalibur; Catalog Numbers 342973, 342975, 34976 In vitro Diagnostics Use.
FDA Enforcement
Class II
·Terminated·BD Biosciences, Systems & Reagents·April 8, 2015
BD Flow Cytometers; used on all BD FACSCount, BD FACSCalibur, BD FACSCanto, BD FACSCanto II, BD LSR II, BD LSRFortessa,BD FACSAria, BD FACSAria II, BD FACSAria Ill, BD lnflux, BD FACSArray,BD Pathway 855, BD Pathway 435 and all SORP instruments. BD Biosciences Flow cytometers for the enumeration of tissue and biological fluid samples such as blood and blood components.
FDA Enforcement
Class III
·Terminated·BD Biosciences, Systems & Reagents·July 22, 2015
BD Multi Check CD4 Low Control Catalog No. 340916 is intended as a complete process control for immunophenotyping by flow cytometry.
FDA Enforcement
Class III
·Terminated·BD Biosciences, Systems & Reagents·August 20, 2014
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