3 results
·
16ms
·
Sources: EU EUDAMED, US FDA
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 the identification, quantification, and characterization of cells in support of cell analysis. BD FACSuite software is loaded onto an adjacent PC workstation and is used to operate the instrument, acquire samples, and analyze data. Quality control performance, tracking, and reporting are streamlined and automated. Routine tasks such as daily cleaning and shutdown can be programmed to occur automatically. The BD FACSuite clinical software allows users to run BD IVD assays.
FDA Enforcement
Class III
·Terminated·Becton, Dickinson and Company, BD Biosciences·February 13, 2019
CytoVision Image Analysis and Capture System, an automated cell-locating device. The Cytovision is a rapid metaphase finder, image acquisition and computer aided chromosome analysis system which assists the operator in viewing chromosomes and looking for cellular anomalies. CytoVision enables a qualified Cytogeneticist to rapidly and accurately analyze the chromosome banding pattern.
FDA Enforcement
Class III
·Terminated·Leica Biosystems Richmond Inc.·June 29, 2016
FilmArray NGDS Warrior Panel, Ref: NGDS-ASY-0007, UDI: (01)00851458005136, IVD, Rx Only
FDA Enforcement
Class III
·Terminated·Biofire Defense·March 11, 2020