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    Coral Clinical Systems, A Division of Tulip Diagnostics (P) Ltd.,

    Manufacturer
    🇮🇳 India

    HCG ER METHOD FOR THE TECHNICON IMMUNO 1 SYSTEM IN-VITRO DIAGNOSTIC CLINICAL METHOD

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    VITROS Immunodiagnostic Products TSH Reagent Pack

    FDA Enforcement
    Class III ·Terminated·Clinical Diagnostic Systems·April 18, 2018

    PROGRAMMING SOFTWARE

    FDA Adverse Event
    Malfunction ·LIVANOVA USA, INC.·Product code LYJ·August 6, 2019

    SOUNDSTAR

    FDA Adverse Event
    Malfunction ·BIOSENSE WEBSTER INC·Product code OBJ·January 19, 2024

    PROGRAMMING SOFTWARE

    FDA Adverse Event
    Malfunction ·LIVANOVA USA, INC.·Product code LYJ·October 7, 2019

    VITROS IMMUNODIAGNOSTIC PRODUCTS TROPI ES REAGENT PACK

    FDA Adverse Event
    Malfunction ·ORTHO-CLINICAL DIAGNOSTICS·Product code MMI·August 28, 2015

    VITROS IMMUNODIAGNOSTIC PRODUCTS TROPI ES REAGENT PACK

    FDA Adverse Event
    Malfunction ·ORTHO-CLINICAL DIAGNOSTICS·Product code MMI·August 28, 2015

    VITROS IMMUNODIAGNOSTIC PRODUCTS TROPI ES REAGENT PACK

    FDA Adverse Event
    Malfunction ·ORTHO-CLINICAL DIAGNOSTICS·Product code MMI·August 3, 2015

    VITROS IMMUNODIAGNOSTIC PRODUCTS TROPI ES REAGENT PACK

    FDA Adverse Event
    Malfunction ·ORTHO-CLINICAL DIAGNOSTICS·Product code MMI·August 3, 2015

    VITROS IMMUNODIAGNOSTIC PRODUCTS TROPI ES REAGENT PACK

    FDA Adverse Event
    Malfunction ·ORTHO-CLINICAL DIAGNOSTICS·Product code MMI·August 3, 2015

    VITROS IMMUNODIAGNOSTIC PRODUCTS TROPI ES REAGENT PACK

    FDA Adverse Event
    Malfunction ·ORTHO-CLINICAL DIAGNOSTICS·Product code MMI·June 23, 2015

    VITROS IMMUNODIAGNOSTIC PRODUCTS TROPONIN I ES REAGENT PACK

    FDA Adverse Event
    Malfunction ·ORTHO-CLINICAL DIAGNOSTICS·Product code MMI·June 24, 2015

    VITROS IMMUNODIAGNOSTIC PRODUCTS TROPONIN I ES REAGENT PACK

    FDA Adverse Event
    Malfunction ·ORTHO-CLINICAL DIAGNOSTICS·Product code MMI·December 23, 2015

    VITROS IMMUNODIAGNOSTIC PRODUCTS TROPONIN I ES REAGENT PACK

    FDA Adverse Event
    Malfunction ·ORTHO-CLINICAL DIAGNOSTICS·Product code MMI·December 16, 2015

    VITROS IMMUNODIAGNOSTIC PRODUCTS TROPI ES REAGENT PACK

    FDA Adverse Event
    Malfunction ·ORTHO-CLINICAL DIAGNOSTICS·Product code MMI·June 25, 2015

    VITROS IMMUNODIAGNOSTICS PRODUCTS TROPI ES REAGENT PACK

    FDA Adverse Event
    Malfunction ·Product code MMI·June 8, 2015

    WAVE CLINICAL PLATFORM

    FDA Adverse Event
    Malfunction ·HILL-ROM CARY·Product code MWI·July 13, 2023

    AFFINITI 70 - 795210

    FDA Adverse Event
    Malfunction ·PHILIPS ULTRASOUND, INC·Product code IYN·December 19, 2019

    WAVE CLINICAL PLATFORM

    FDA Adverse Event
    Malfunction ·HILL-ROM CARY·Product code MWI·July 24, 2023