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    MAS Omni-IMMUNE Liquid Assayed Integrated Immunoassay Control

    FDA UDI
    Microgenics Corporation·00884883005389·

    MAS Omni-IMMUNE Liquid Assayed Integrated Immunoassay Control

    FDA UDI
    Microgenics Corporation·00884883005396·

    MAS Omni-IMMUNE Liquid Assayed Integrated Immunoassay Control

    FDA UDI
    Microgenics Corporation·00884883005365·

    MAS Omni-IMMUNE Liquid Assayed Integrated Immunoassay Control

    FDA UDI
    Microgenics Corporation·00884883005372·

    VITROS IMMUNODIAGNOSTIC PRODUCTS INTACT PTH REAGENT PACK

    FDA Adverse Event
    Malfunction ·ORTHO-CLINICAL DIAGNOSTICS·Product code CEW·September 30, 2022

    VITROS IMMUNODIAGNOSTIC PRODUCTS INTACT PTH REAGENT PACK

    FDA Adverse Event
    Malfunction ·ORTHO-CLINICAL DIAGNOSTICS, INC.·Product code CEW·May 24, 2023

    VITROS IMMUNODIAGNOSTIC PRODUCTS INTACT PTH REAGENT PACK

    FDA Adverse Event
    Malfunction ·ORTHO-CLINICAL DIAGNOSTICS, INC.·Product code CEW·May 24, 2023

    VITROS IMMUNODIAGNOSTIC PRODUCTS INTACT PTH REAGENT PACK

    FDA Adverse Event
    Malfunction ·ORTHO-CLINICAL DIAGNOSTICS, INC.·Product code CEW·November 7, 2023

    VITROS IMMUNODIAGNOSTIC PRODUCTS INTACT PTH REAGENT PACK

    FDA Adverse Event
    Malfunction ·ORTHO-CLINICAL DIAGNOSTICS·Product code CEW·December 14, 2022

    VITROS IMMUNODIAGNOSTIC PRODUCTS INTACT PTH REAGENT PACK

    FDA Adverse Event
    Malfunction ·ORTHO-CLINICAL DIAGNOSTICS·Product code CEW·December 14, 2022

    MAS Omni Immune Controls

    FDA Enforcement
    Class III ·Terminated·Microgenics Corporation·July 2, 2014

    Thermo Scientific MAS Omni IMMUNE and Omni IMMUNE PRO; Liquid Assayed Integrated Immunoassay Control. Intended for use as an assayed control for monitoring assay conditions in many clinical laboratory determinations. Assay values are provided for the specific systems listed. The user can compare observations with expected ranges as a means of assuring consistent performance or reagent and instrument. .

    FDA Enforcement
    Class III ·Terminated·Microgenics Corporation·November 28, 2012

    OLSEN

    FDA Adverse Event
    Other ·OLSEN MEDICAL·Product code GEI·March 12, 2009

    ARIS TRANSOBTURATOR SLING (COLOPLAST)

    FDA Adverse Event
    Injury ·COLOPLAST A/S·Product code OTN·August 27, 2021

    VITROS IMMUNODIAGNOSTIC PRODUCTS INTACT PTH REAGENT PACK

    FDA Adverse Event
    Malfunction ·ORTHO-CLINICAL DIAGNOSTICS·Product code CEW·December 14, 2022

    VITROS IMMUNODIAGNOSTIC PRODUCTS INTACT PTH REAGENT PACK

    FDA Adverse Event
    Malfunction ·ORTHO-CLINICAL DIAGNOSTICS·Product code CEW·December 14, 2022

    VITROS IMMUNODIAGNOSTIC PRODUCTS INTACT PTH REAGENT PACK

    FDA Adverse Event
    Malfunction ·ORTHO-CLINICAL DIAGNOSTICS, INC.·Product code CEW·September 25, 2023

    VITROS IMMUNODIAGNOSTIC PRODUCTS INTACT PTH REAGENT PACK

    FDA Adverse Event
    Malfunction ·ORTHO-CLINICAL DIAGNOSTICS, INC.·Product code CEW·November 7, 2023

    VITROS IMMUNODIAGNOSTIC PRODUCTS INTACT PTH REAGENT PACK

    FDA Adverse Event
    Malfunction ·ORTHO-CLINICAL DIAGNOSTICS, INC.·Product code CEW·November 7, 2023

    Mri Disposable Kit

    FDA classification
    FDA Class 2 ·Mri Disposable Kit