Vitros

  • Modèle / numéro de série
    All Vitros ECi units currently on the market (software version 3.1 or lower).
  • Classification du dispositif
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide and worldwide distribution of the VITROS ECi Immunodiagnostic systems.
  • Description du dispositif
    Vitros ECi Immunodiagnostic System, sold as Cat. #863 3893; Cat. #192 2814 (Vitros ECiQ), and Cat. #680 1059 (recertified Vitros ECi) when using Vitros Anti-HBc IgM Reagent Packs and Anti-HAV IgM Reagent Packs. NOTE: These 3 catalog numbers of Vitros ECi represent the original unit, an updated unit with cosmetic changes only, and refurbished units.
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Ortho-Clinical Diagnostics, 100 Indigo Creek Drive, Rochester NY 14626
  • Source
    USFDA

888 dispositifs médicaux avec un nom similaire

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  • Modèle / numéro de série
    Version 2.6.1 & Below
  • Classification du dispositif
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) and the countries of Australia, New Zealand, Brazil, Canada, Chile, Argentina, Paraquay, Ecuador, Colombia, India, Japan, Mexico, Panama, Singapore, Venezuela, UK, Northern Europe, France, Germany, Italy, Spain and Portugal.
  • Description du dispositif
    VITROS 5,1 FS System Software || For use in the in-vitro quantitative, semi quantitative, and qualitative measurement of variety of analytes of clinical interest.
  • Manufacturer
  • Modèle / numéro de série
    Version 2.0 & Below
  • Classification du dispositif
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) and the countries of Australia, New Zealand, Brazil, Canada, Chile, Argentina, Paraquay, Ecuador, Colombia, India, Japan, Mexico, Panama, Singapore, Venezuela, UK, Northern Europe, France, Germany, Italy, Spain and Portugal.
  • Description du dispositif
    VITROS 4600 Chemistry System Software || For use in the in-vitro quantitative, semi quantitative, and qualitative measurement of variety of analytes of clinical interest.
  • Manufacturer
  • Modèle / numéro de série
    Version 2.0 & Below
  • Classification du dispositif
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) and the countries of Australia, New Zealand, Brazil, Canada, Chile, Argentina, Paraquay, Ecuador, Colombia, India, Japan, Mexico, Panama, Singapore, Venezuela, UK, Northern Europe, France, Germany, Italy, Spain and Portugal.
  • Description du dispositif
    VITROS 5600 Integrated System Software || For use in the in-vitro quantitative, semi quantitative, and qualitative measurement of variety of analytes of clinical interest.
  • Manufacturer
  • Modèle / numéro de série
    Lots from coating 0204, 0205, 0206. A Coating (CTG) is a unique identifier within the Lot Number of some of OCDs products
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - US (nationwide)
  • Description du dispositif
    VITROS Chemistry Products DGXN Slides --- [REF] 834 3386. Product is packaged in a box with multiple slides. The lot and expiration codes are found on the side of the package. || Product Usage: Intended use: For in vitro diagnostic use only. VITROS Chemistry Products DGXN Slides quantitatively measure digoxin (DGXN) concentration in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.
  • Manufacturer
  • Modèle / numéro de série
    CAT No. 680 0100; the cartridges do not have lot numbers.
  • Classification du dispositif
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution, including Nationwide (USA) and the countries of AU, GM, FR, IT, SP, BR, BM, AR, CA, JA, MX, UK, CH, CL, CO, IN, EC, PE, PY, PA, PT, NZ, SG, VE and UY.
  • Description du dispositif
    Ortho Clinical Diagnostics VITROS¿ Chemistry Products Vapor Adsorption Cartridge REF/CAT No. 680 0100. VITROS¿ Vapor Adsorption Cartridges are used to remove vapor contaminants that may potentially interfere with Signal Reagent used with MicroWell Assays on the VITROS¿ 3600, VITROS¿ 5600, and VITROS¿ ECi/ECiQ Systems.
  • Manufacturer
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