Devices

Device Recall MagNA Pure 96 System

  • Modèle / numéro de série
    Serial Numbers 2001, 2002, 2003, 2004, 2006, 2011, 2012, 2013, 2014, 2015, 2016, 2018, 2019, 2020, 2021, 2022, 2023, 2024, 2025, 2026, 2027, 2028, 4001, 4022, 4023, 4024, 4025.
  • Classification du dispositif
    Clinical Chemistry and Clinical Toxicology Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    US Distribution including the states of AL, AZ, CA, CT, GA, NY, NC, NJ, OH, TX, VA and WA.
  • Description du dispositif
    MagNA Pure 96 System || Version 1.0 || Software Version 2.0 || Robotic workstation for automated isolation of nucleic acids from different kinds of crude sample material (whole blood, serum, blood cells, culture cells, tissue, bacteria, fungi) by the use of the specially designed MagNA Pure reagent kits, automated filling of different kinds of PCR reaction vessels.
  • Manufacturer
    Roche Diagnostics Operations, Inc.
  • 1 Event

Fabricant

Roche Diagnostics Operations, Inc.
  • Adresse du fabricant
    Roche Diagnostics Operations, Inc., 9115 Hague Rd, Indianapolis IN 46256-1025
  • Société-mère du fabricant (2017)
    Roche Holding AG
  • Source
    USFDA

Un dispositif médical avec un nom similaire

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Device Recall MagNA Pure 96 System
  • Modèle / numéro de série
    Device-associated diagnostic software
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Classe de dispositif
    Unclassified
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution
  • Description du dispositif
    The MagNA Pure 96 System (versions 1.0 and 2.0) is a sample preparation instrument for automated isolation of nucleic acids in various types of biological materials. This is a general purpose instrument. There are no corresponding assays.
  • Manufacturer
    Roche Molecular Systems, Inc.