BEUDAMED
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    ALINITY I ESTRADIOL REAGENT KIT

    FDA Adverse Event
    Injury ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code CHP·June 17, 2024

    Quest EIA ANA Screen Bulk Kit, model number 96AN-BPU-QUEST. Manufactured by Bio-Rad Laboratories, Inc., Hercules, CA. For labeling and distribution by Quest International Inc. Medical device is used as a qualitative enzyme immunoassay (EIA) intended to screen for the presence of antinuclear antibodies (ANAs) in human serum as an aid in the diagnosis of certain rheumatic diseases. This assay collectively detects, in one well, total ANAs against double stranded DNA (dsDNA, nDNA), histones, SS-A/Ro, SS-B/LA, Sm, Sm/RNP, Scl-70, Jo-1 and centromeric antigens along with sera positive for Immunofluorescent (IFA) HEp-2.

    FDA Recall
    Terminated ·Bio-Rad Laboratories Inc·Product code LKJ·February 26, 2010

    QbD RepS BV

    Authorized representative
    🇧🇪 Belgium·86 Manufacturers·1555 Devices

    MedNet EC-REP GmbH

    Authorized representative
    🇩🇪 Germany·464 Manufacturers·5263 Devices

    Emergo Europe B.V.

    Authorized representative
    🇳🇱 Netherlands·900 Manufacturers·22100 Devices

    Luxus Lebenswelt GmbH

    Authorized representative
    🇩🇪 Germany·191 Manufacturers·2068 Devices