Roche Diagnostics Operations, Inc.

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Description

84 dispositivos en la base de datos

  • Modelo / Serial
    Lot Numbers 15621900, 15617800, 15622600, 15616900, 15816200 and 15815600.
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution.
  • Descripción del producto
    Roche/Hitachi GENT2 ONLINE TDM Gentamicin for Roche cobas c 501 analyzer systems; Catalog no. 04490843190. || The product is used for in vitro diagnostic reagent for the quantitative determination of gentamicin in human serum or plasma on automated clinical chemistry analyzers.
  • Modelo / Serial
    Lot Numbers 15622600, 15617800, 15616900 and 15816200.
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution.
  • Descripción del producto
    Roche/Hitachi cobas ONLINE TDM Gentamicin for Roche analyzer models 917 and Modular P; Catalog no. 03500241190. || The product is used for in vitro diagnostic reagent for the quantitative determination of gentamicin in human serum or plasma on automated clinical chemistry analyzers.
  • Modelo / Serial
    Lot Numbers 15617800, 15622600, 15616900 and 15621900.
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution.
  • Descripción del producto
    Roche/Hitachi cobas ONLINE TDM Gentamicin for Roche analyzer models 911, 912, 917 and Modular P; Catalog no. 03800504190. || The product is used for in vitro diagnostic reagent for the quantitative determination of gentamicin in human serum or plasma on automated clinical chemistry analyzers.
  • Modelo / Serial
    Models: cobas b 123 <2> POC system: 05122252001 cobas b 123 < 4 > POC system: 05122287001 Serial numbers: 11074  2274  2550  2302  2304  2309  1253  2420  2337  2147  2389  2418  2425  1749  2462  2338  2339  1850  2328  2500  1374  2301  1349  2400  2344  2350  1860  1941  2006  2128
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution including CA, LA, NE, PR, SC, TX, VA, and WV
  • Descripción del producto
    Cobas b 123 POC system || The cobas b 123 POC system is a fully automated POC system for whole blood in vitro measurement of pH, blood gases (B3G), electrolytes Nat, K+, iCaWt (ISE), hematocrit (THct), metabolites (Glu, Lac), total hemoglobin (tHb), hemoglobin derivatives (O2Hb, HHb, COT~b, MetHb), and oxygen saturation (SO2). In addition, the cobas b 123 POC system calculates derived parameters. It is dedicated for use in a Point-of-Care environment and laboratory. The integrated AutoQC module and the oximeter module are available as an option
  • Modelo / Serial
    Lot Number(s): All lots within shelf life. Expiration Date(s): All
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution including ALCA CO CT FL IL IN KS MD MI MO NC NE NJ NM NY OH OK PA PR SC TX VA and WI
  • Descripción del producto
    MSS CASSETTE GLU/LAC/UREA (BUN) as a part of the || Roche OMNI S Analyzer: cobas b 221<6>Roche OMNI S6 system || The Roche Diagnostics Omni S Analyzer is a fully automated critical care analyzer intended to be used for the measurement of pH, PCO2, PO2, sodium, potassium, ionized calcium, chloride, hematocrit, glucose, lactate, urea/BUN, total hemoglobin, oxygen saturation, oxyhemoglobin, deoxyhemoglobin, carboxyhemoglobin, and methemoglobin in samples of whole blood, serum, plasma, and aqueous solutions as appropriate
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Más información acerca de la data acá

  • Dirección del fabricante
    Roche Diagnostics Operations, Inc., 9115 Hague Road, Indianapolis IN 46256-1025
  • Empresa matriz del fabricante (2017)
  • Source
    USFDA
  • Dirección del fabricante
    Roche Diagnostics Operations, inc., 9115 Hague Rd, Indianapolis IN 46256-1025
  • Empresa matriz del fabricante (2017)
  • Source
    USFDA
  • Dirección del fabricante
    Roche Diagnostics Operations, Inc., 9115 Hague Road, Indianapolis IN 46256
  • Empresa matriz del fabricante (2017)
  • Source
    USFDA