Device Recall Biomerieux

  • Modelo / Serial
    VITEK¿ 2 ANC (ref: 21347): Lot Number 2440318203
  • Clasificación del producto
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    International distribution.
  • Descripción del producto
    The VITEK¿ 2 Anaerobic and Corynebacteria identification card (ANC) is intended for use with the VITEK¿ 2 Systems for the automated identification of most clinically significant anaerobic organisms and Corynebatcerium species. The VITEK¿ 2 ANC identification card is a single-use disposable. || A microorganism differentiation and identification device is a device intended for medical purposes that consists of one or more components, such as differential culture media, biochemical reagents, and paper discs or paper strips impregnated with test reagents, that are usually contained in individual compartments and used to differentiate and identify selected microorganisms. The device aids in the diagnosis of disease.
  • Manufacturer
  • 1 Event

Fabricante

  • Dirección del fabricante
    BioMerieux SA, Chemin De L'Orme, Marcy L'Etoile France
  • Empresa matriz del fabricante (2017)
  • Source
    USFDA

9 dispositivos con un nombre similar

Más información acerca de la data acá

  • Modelo / Serial
    VITEK 2 NH (ref: 21346): Lot Number 2450355203
  • Clasificación del producto
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    International distribution.
  • Descripción del producto
    The VITEK 2 Neisseria-Haemophilus identification card (NH) is intended for use with the VITEK 2 Systems for the automated identification of most clinically significant fastidious organisms. The VITEK 2 NH identification card is a single-use disposable. || A microorganism differentiation and identification device is a device intended for medical purposes that consists of one or more components, such as differential culture media, biochemical reagents, and paper discs or paper strips impregnated with test reagents, that are usually contained in individual compartments and used to differentiate and identify selected microorganisms. The device aids in the diagnosis of disease.
  • Manufacturer
  • Modelo / Serial
    VITEK¿ 2 AST-P606 (ref: 22330): Lot Number 4860117403
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    International distribution.
  • Descripción del producto
    The VITEK¿ 2 Gram Positive Susceptibility Card is intended for use with the VITEK 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of Staphylococcus spp., Enterococcus spp., and S. agalactiae to antimicrobial agents. || Fully automated short-term incubation cycle antimicrobial susceptibility system is a device that incorporates concentrations of antimicrobial agents into a system for the purpose of determining in vitro susceptibility of bacterial pathogens isolated from clinical specimens. Test results obtained from short-term (less than 16 hours) incubation are used to determine the antimicrobial agent of choice to treat bacterial diseases.
  • Manufacturer
  • Modelo / Serial
    VITEK¿ 2 AST-N233 (ref: 413117): Lot Number 6330343103
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    International distribution.
  • Descripción del producto
    The VITEK 2 Gram Negative Susceptibility Card is intended for use with the VITEK 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of clinically significant aerobic gram negative bacilli to antimicrobial agents. || Fully automated short-term incubation cycle antimicrobial susceptibility system is a device that incorporates concentrations of antimicrobial agents into a system for the purpose of determining in vitro susceptibility of bacterial pathogens isolated from clinical specimens. Test results obtained from short-term (less than 16 hours) incubation are used to determine the antimicrobial agent of choice to treat bacterial diseases.
  • Manufacturer
  • Modelo / Serial
    VIDAS¿ TOXO IgG AVIDITY (ref: 30222): Lot Number 1005621420
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    International distribution.
  • Descripción del producto
    VIDAS TOXO IgG Avidity is an automated qualitative test for use on the VIDAS family instruments, for the determination of anti-toxoplasma IgG avidity in human serum or plasma (lithium heparin, sodium citrate, EDTA) using the ELFA technique (Enzyme Linked Fluorescent Assay). || Toxoplasma gondii serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to Toxoplasma gondii in serum. Additionally, some of these reagents consist of antisera conjugated with a fluorescent dye (immunofluorescent reagents) used to identify Toxoplasma gondii from clinical specimens.
  • Manufacturer
  • Modelo / Serial
    Reagents for use with the PREVI¿ Color Gram:  IODINE-B (ref: 29523) Lot number: G59407 Exp. 15-Aug-18 CRYSTAL VIOLET-C (ref: 29524) Lot number: G52306 Exp.19-Jul-18 FUCHSIN-A (ref: 29522): Lot Number Lot number: F89544 Exp. 13-Apr-18
  • Clasificación del producto
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    International distribution.
  • Descripción del producto
    The PREVI¿ Color Gram dyes are used with the PREVI¿ Color Gram instrument to stain bacterial and fungal microorganisms for direct examination, according to Gram s method. || The PREVI¿ Color Gram instrument sprays the PREVI¿ Color Gram reagents onto microscope slides which have been smeared with specimens to be examined. The staining procedure is rapid and precise. Each reagent has a specific position (A, B, C, D, E) on the PREVI¿ Color Gram platform that is also indicated on the reagent label. || An automated slide stainer is a device used to stain histology, cytology, and hematology slides for diagnosis.
  • Manufacturer
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