BEUDAMED
    82 results · 31ms · Sources: EU EUDAMED, US FDA

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    ARCHITECT CA 19-9XR ASSAY

    FDA 510(k)
    FDA Class 2 ·Immunology

    ARCHITECT CA19-9XR

    FDA Adverse Event
    Malfunction ·ABBOTT GMBH·Product code NIG·October 31, 2025

    ALINITY I CA 19-9XR REAGENT KIT

    FDA Adverse Event
    Malfunction ·ABBOTT GMBH·Product code NIG·May 19, 2026

    ALINITY I CA 19-9XR REAGENT KIT

    FDA Adverse Event
    Malfunction ·ABBOTT GMBH·Product code NIG·May 1, 2026

    ALINITY I CA 19-9XR REAGENT KIT

    FDA Adverse Event
    Malfunction ·ABBOTT GMBH·Product code NIG·May 14, 2026

    ALINITY I CA 19-9XR REAGENT KIT

    FDA Adverse Event
    Malfunction ·ABBOTT GMBH·Product code NIG·December 9, 2025

    ARCHITECT CA19-9XR

    FDA Adverse Event
    Malfunction ·ABBOTT GMBH·Product code NIG·December 22, 2025

    ARCHITECT CA19-9XR

    FDA Adverse Event
    Malfunction ·ABBOTT GMBH·Product code NIG·April 3, 2026

    ALINITY I CA 19-9XR REAGENT KIT

    FDA Adverse Event
    Malfunction ·ABBOTT GMBH·Product code NIG·November 4, 2025

    ARCHITECT CA19-9XR

    FDA Adverse Event
    Malfunction ·ABBOTT GMBH·Product code NIG·December 22, 2025

    ALINITY I CA 19-9XR REAGENT KIT

    FDA Adverse Event
    Malfunction ·ABBOTT GMBH·Product code NIG·July 29, 2025

    ALINITY I CA 19-9XR REAGENT KIT

    FDA Adverse Event
    Malfunction ·ABBOTT GMBH·Product code NIG·April 28, 2025

    ARCHITECT CA19-9XR REAGENT KIT

    FDA Adverse Event
    Malfunction ·ABBOTT GMBH·Product code NIG·June 4, 2025

    ALINITY I CA 19-9XR REAGENT KIT

    FDA Adverse Event
    Malfunction ·ABBOTT GMBH·Product code NIG·June 30, 2025

    ALINITY I CA 19-9XR REAGENT KIT

    FDA Adverse Event
    Malfunction ·ABBOTT GMBH·Product code NIG·April 28, 2025

    ARCHITECT CA19-9XR

    FDA Adverse Event
    Malfunction ·ABBOTT GMBH·Product code NIG·February 11, 2026

    ARCHITECT CA19-9XR REAGENT KIT

    FDA Adverse Event
    Malfunction ·ABBOTT GMBH·Product code NIG·February 5, 2025

    ALINITY I CA 19-9XR REAGENT KIT

    FDA Adverse Event
    Malfunction ·ABBOTT GMBH·Product code NIG·October 31, 2025

    ALINITY I CA 19-9XR REAGENT KIT

    FDA Adverse Event
    Malfunction ·ABBOTT GMBH·Product code NIG·October 15, 2025

    ARCHITECT CA19-9XR

    FDA Adverse Event
    Malfunction ·ABBOTT GMBH·Product code NIG·December 23, 2025