4 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: Class Iii
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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 diagnostic use in the identification of cells expressing FMC7 antigen.
FDA Enforcement
Class III
·Terminated·Becton, Dickinson and Company, BD Biosciences·March 2, 2016
BD-Retic-Count Reticulocyte Reagent System; Hematology: Used for in vitro diagnostics
FDA Enforcement
Class III
·Terminated·Becton, Dickinson and Company, BD Biosciences·April 20, 2016
BD MAX Instrument, catalog #441916 Product Usage: The BD MAX System, used in conjunction with the appropriate extraction kits and reagents is capable of automated amplification and detection of target nucleic acid sequences for use in clinical, industrial, and research settings.
FDA Enforcement
Class III
·Terminated·Becton Dickinson & Co.·July 10, 2013
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.
FDA Enforcement
Class III
·Terminated·Becton, Dickinson and Company, BD Biosciences·November 4, 2015