BEUDAMED
    2 results · 19ms · Sources: EU EUDAMED, US FDA

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    TDHistology/Cytology Classification name: Calculator/data processing module for clinical use (862.2100). Intended use: Laboratory Information System (L.I.S)

    FDA Enforcement
    Class III ·Terminated·Technidata S.A.·July 24, 2013

    The CF-70 instrument (product code: LXG; Regulation Number: 862.2050) receives magazines containing stained blood smears from SP-50, selects only smears that require analysis, and transports them to the DI-60 for further analysis. After completing the analysis on DI-60 the smears are placed back in magazines.

    FDA Enforcement
    Class II ·Terminated·Sysmex America, Inc.·April 22, 2020