Devices

Device Recall Perkin Elmer Specimen Gate Systems

  • Modelo / Serial
    Software Versions: 1.2 and 1.3.
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution -- United States (AL, AZ, CA, CO, CT, FL, GA, IN, KS, KY, MI, MO, OH, OK, OR, TN and TX) and Canada.
  • Descripción del producto
    Specimen Gate Laboratory, Product Code: 5002-0180, Software Version: 1.2 and 1.3. || The intended use of the product is data management in prenatal and neonatal screening laboratories designed to allow viewing and management of assay results.
  • Manufacturer
    Perkin Elmer
  • 1 Event

Fabricante

Perkin Elmer
  • Dirección del fabricante
    Perkin Elmer, 940 Winter St, Waltham MA 02451-1457
  • Empresa matriz del fabricante (2017)
    Perkin Elmer Inc.
  • Source
    USFDA

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Device Recall Perkin Elmer Specimen Gate Systems
  • Modelo / Serial
    Software versions: 1.2 and 1.3.
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution -- United States (AL, AZ, CA, CO, CT, FL, GA, IN, KS, KY, MI, MO, OH, OK, OR, TN and TX) and Canada.
  • Descripción del producto
    Specimen Gate Lab - MSMS Data Suite, Product Code: 5002-0310. || The intended use of the product is data management in prenatal and neonatal screening laboratories designed to allow viewing and management of assay results.
  • Manufacturer
    Perkin Elmer