VITROS 3600

  • Modèle / numéro de série
    All VITROS¿ 3600 Systems Catalog # 6802783 that have not been eConnected which may have Assay Data Disk (ADD) Data Release Version (DRV) 9241 or 9251. J/Serial Numbers: 36000206, 36000268, 36000269, 36000290, 36000319, 36000404, 36000414, 36000416, 36000426,  36000430, 36000453, 36000464, 36000466, 36000467, 36000475, 36000143, 36000151, 36000152, 36000159, 36000165, 36000187, 36000194, 36000198, 36000204, 36000222, 36000228, 36000257, 36000258, 36000271, 36000275, 36000279, 36000301, 36000306, 36000307, 36000313, 36000315, 36000322, 36000324, 36000325, 36000326, 36000327, 36000330, 36000332, 36000333, 36000335, 36000336, 36000338, 36000342, 36000347, 36000348, 36000352, 36000353, 36000355, 36000360, 36000364, 36000365, 36000372, 36000374, 36000382, 36000384, 36000389, 36000390, 36000391, 36000392, 36000394, 36000395, 36000400, 36000401, 36000403, 36000405, 36000408, 36000421, 36000422, 36000425, 36000429, 36000431, 36000434, 36000438, 36000441, 36000442, 36000443, 36000448, 36000461, 36000462, 36000468, 36000469, 36000470, 36000471, 36000472, 36000473, 36000476, 36000477, 36000478, 36000479, 36000481, 36000483. -- NOTE: VITROS¿ 3600 that are e-Connected are not affected by this issue.
  • Classification du dispositif
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) including the countries of: Brazil, Canada, Chile, China, England, France, Germany, India, Italy, Japan, Mexico, Singapore, Spain and Venezuela.
  • Description du dispositif
    VITROS¿ 3600 Immunodiagnostics Systems, Catalog # 6802783; COMMON/USUAL NAME: VITROS¿ 3600 --- NOTE: VITROS¿ 3600 that are e-Connected are not affected by this issue. || Product Usage: || For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS¿ Immunodiagnostic Products Reagents.
  • Manufacturer
  • 1 Event

Fabricant

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

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  • Modèle / numéro de série
  • Manufacturer
    N/A
  • Modèle / numéro de série
    6802783, Software Version 3.2.2 and earlier.
  • Description du dispositif
    This equipment is designed for the quantitative, semiquantitative and qualitative measurement of a great variety of analytes of clinical interest.
  • Manufacturer
  • Modèle / numéro de série
  • Description du dispositif
    (1) - (3) Discrete method Clinical chemistry automatic analyzer / dry clinical chemistry analyzer / immunoluminescence measuring device / ion selectivity analyzer
  • Manufacturer
41 en plus