BEUDAMED
    13 results · 51ms · 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 Regulation: Us FDA ×

    Immunodiagnostic Systems SA

    FDA registration
    Immunodiagnostic Systems SA·1 product·🇧🇪 Belgium

    IDS-iSYS Wash Solution (Wash S)

    FDA UDI
    Immunodiagnostic Systems SA·05425030421031·

    IDS-iSYS System Liquid (Syst. l)

    FDA UDI
    Immunodiagnostic Systems SA·05425030421017·

    IDS-iSYS Trigger Set

    FDA UDI
    Immunodiagnostic Systems SA·05425030421024·

    IDS-iSYS Cartridge Check System (CCS)

    FDA UDI
    Immunodiagnostic Systems SA·05425030426012·

    VITROS ECIQ IMMUNODIAGNOSTIC SYSTEM

    FDA Adverse Event
    Malfunction ·ORTHO-CLINICAL DIAGNOSTICS·Product code KHO·December 11, 2017

    VIDAS FSH, Ref 30407-01, IVD, Rx. The firm name on the label is bioMerieux SA, France. For use on the instruments of the VIDAS family (VITEK ImmunoDiagnostic Assay System) as an automated quantitative enzyme-linked fluorescent immunoassay (ELFA) for the determination of human follicle stimulating hormone (FSH) concentration in human serum or plasma (heparin). It is intended for use as an aid in the diagnosis of pituitary gland and gonadal disorders.

    FDA Enforcement
    Class II ·Terminated·BioMerieux SA·July 4, 2018

    VITROS IMMUNODIAGNOSTIC PRODUCTS TOTAL B HCG II REAGENT PACK

    FDA Adverse Event
    Malfunction ·ORTHO-CLINICAL DIAGNOSTICS·Product code DHA·August 24, 2022

    VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-SARS-COV-2 IGG REAGENT PACK

    FDA Adverse Event
    Malfunction ·ORTHO-CLINICAL DIAGNOSTICS·Product code QKO·February 11, 2021

    VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC REAGENT PACK

    FDA Adverse Event
    Malfunction ·ORTHO-CLINICAL DIAGNOSTICS·Product code LOM·October 11, 2019

    VIDAS® 3

    FDA Adverse Event
    Malfunction ·BIOMÉRIEUX SA·Product code JJE·February 17, 2022

    VIDAS FSH, Ref 30407-01, IVD, Rx. The firm name on the label is bioMerieux SA, France. For use on the instruments of the VIDAS family (VITEK ImmunoDiagnostic Assay System) as an automated quantitative enzyme-linked fluorescent immunoassay (ELFA) for the determination of human follicle stimulating hormone (FSH) concentration in human serum or plasma (heparin). It is intended for use as an aid in the diagnosis of pituitary gland and gonadal disorders.

    FDA Recall
    Terminated ·BioMerieux SA Chemin De L'Orme Marcy L'Etoile France·Product code CGJ·April 9, 2018

    VITROS IMMUNODIAGNOSTIC PRODUCTS HS TROPONIN I (HSTNI) REAGENT PACK

    FDA Adverse Event
    Malfunction ·ORTHO-CLINICAL DIAGNOSTICS, INC.·Product code MMI·May 14, 2026