BEUDAMED
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    BIOCARTIS NV

    FDA registration
    BIOCARTIS NV·4 products·🇧🇪 Belgium

    Idylla™ Respiratory (IFV-RSV) Panel

    FDA UDI
    Biocartis NV·15415219000635·

    Idylla™ System

    FDA UDI
    Biocartis NV·05415219000119·Up to eight Idylla™ Instruments and the Idylla™...

    Idylla™ System

    FDA UDI
    Biocartis NV·05415219000126·The Idylla™ Console is a computer with a vertic...

    Idylla™ MSI Test

    FDA UDI
    Biocartis NV·15415219000758·The Idylla MSI Test, for use on the Idylla Syst...

    Idylla CDx MSI Test

    FDA UDI
    Biocartis NV·15415219001328·For in vitro diagnostic use. For Prescription U...

    Idylla INSTRUMENT, IVD, REF P0010. Intended for the detection of nucleic acid targets in various types of human samples, using disposable Test-specific ldylla Cartridges.

    FDA Enforcement
    Class II ·Ongoing·Biocartis Nv·January 22, 2025

    Idylla INSTRUMENT, IVD, REF P0010. Intended for the detection of nucleic acid targets in various types of human samples, using disposable Test-specific ldylla Cartridges.

    FDA Recall
    Open, Classified ·Biocartis Nv B 3 Generaal De Wittelaan 11 Mechelen Belgium·Product code OOI·December 10, 2024