BEUDAMED
    3 results · 6ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Classification: Class Ii × Status: Terminated × Clear all

    QUIDEL Sofia SARS Antigen FIA IVD REF 20374

    FDA Enforcement
    Class II ·Terminated·Quidel Corporation·November 18, 2020

    Quidel, Sofia Influenza A + B FIA, Kit #20218 (25-Test Kit), in vitro diagnostic.

    FDA Enforcement
    Class II ·Terminated·Quidel Corporation·February 20, 2013

    Sofia SARS Antigen FIA Package Insert The Sofia SARS Antigen FIA is a lateral flow immunofluorescent sandwich assay that is used with the Sofia and Sofia 2 instrument intended for the qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 in nasopharyngeal (NP) and nasal (NS) swab specimens directly from individuals who are suspected of COVID-19 by their healthcare provider within the first five days of the onset of symptoms.

    FDA Enforcement
    Class II ·Terminated·Quidel Corporation·October 28, 2020