9 results
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26ms
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Sources: EU EUDAMED, US FDA
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Classification: Class Iii
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BD FocalPoint Slide Profiler and BD FocalPoint GS Review Station; Catalog Nos. 490398, 490653, 491085, 491086, 491090, 490189 The BD FocalPoint GS Imaging System is intended to assist in cervical cancer screening of BD SurePath Liquid-based Pap Test slides to detect evidence of squamous carcinoma, adenocarcinoma and their usual precursor conditions.
FDA Enforcement
Class III
·Terminated·Becton Dickinson & Co.·October 17, 2018
BD MAX DNA MMK (SPC) For Laboratory Use, catalog no. 442829
FDA Enforcement
Class III
·Terminated·Becton Dickinson & Co.·May 9, 2018
PhoenixSpec AP Calibrator is used to calibrate the PhoenixSpec & Phoenix AP Instruments. The instruments are then used to measure the turbidity of microbial suspensions equivalent to McFarland standards 0.10 to 4.50.
FDA Enforcement
Class III
·Terminated·Becton Dickinson & Co.·November 2, 2016
PhoenixSpec Calibrator & Kit is used to calibrate the PhoenixSpec & Phoenix AP Instruments. The instruments are then used to measure the turbidity of microbial suspensions equivalent to McFarland standards 0.10 to 4.50.
FDA Enforcement
Class III
·Terminated·Becton Dickinson & Co.·November 2, 2016
BBL CrystaLEAD Enteric/Nonfermentor (E/NF) Identification (ID) System, catalog number 245000. in vitro diagnostic for the identification of aerobic gram-negative bacteria that belong to the family Enterobacteriaceae as well as some of the more frequently isolated glucose fermenting and nonfermenting gram-negative bacilli.
FDA Enforcement
Class III
·Terminated·Becton Dickinson & Co.·July 23, 2014
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
BBL Trypticase Soy Agar with 5% Sheep Blood (TSA II) and Chocolate II Agar (GC II Agar with Hemoglobin and IsoVitaleX) I Plate Product Usage: Testing - Trypticase Soy Agar with 5% Sheep Blood is used for the growth of fastidious organisms and for the visualization of hemolytic reactions. Chocolate II Agar is an enriched medium for the isolation and cultivation of Neisseria species.
FDA Enforcement
Class III
·Terminated·Becton Dickinson & Co.·May 3, 2017
BD MAX DNA MMK Lab Use, catalog no. 442828
FDA Enforcement
Class III
·Terminated·Becton Dickinson & Co.·May 9, 2018
BD PhoenixTM AP, Catalog Number 448010 The BD Phoenix" AP instrument is designed for use with the BD Phoenix" system is intended to standardize ID broth tube inoculum, add AST indicator to the AST broth tube and transfer an aliquot of ID broth to AST broth tubes, as required for preparing samples for use on the BD Phoenix" system, which performs identification and susceptibility testing
FDA Enforcement
Class III
·Terminated·Becton Dickinson & Co.·December 13, 2017