Devices

Cobas

  • Modelo / Serial
    Lot #s: 70712A (6 kits); 70601W (76 kits); 70713A (4 kits); 70718A (50 kits); and 70809A (kits were not distributed to end users).
  • Clasificación del producto
    Immunology and Microbiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide distribution. Austria, Denmark, Germany, Singapore, Netherlands, Hong Kong, and Switzerland. US product is not affected.
  • Descripción del producto
    Nucleic Acid test intended for screening for MRSA/SA. Each kit has 20 tubes. in vitro diagnostic.
  • Manufacturer
    Roche Molecular Systems, Inc.
  • 1 Event

Fabricante

Roche Molecular Systems, Inc.
  • Dirección del fabricante
    Roche Molecular Systems, Inc., 1080 US Highway 202 S, Branchburg NJ 08876-3733
  • Empresa matriz del fabricante (2017)
    Roche Holding AG
  • Source
    USFDA

918 dispositivos con un nombre similar

Más información acerca de la data acá

Device Recall cobas p 512 preanalytical system
  • Modelo / Serial
    Part numbers:05083435001 and 06268854001
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    US Distribution including Puerto Rico and to the states of :TX, OH, TN, AZ, WA, MI and GA
  • Descripción del producto
    cobas p 512 pre-analytical system || Pre-analytical sample handling that includes de-capping, aliquoting and sorting of samples for analysis.
  • Manufacturer
    Roche Diagnostics Operations, Inc.
Device Recall cobas Liat Analyzer
Device Recall cobas Liat Influenza A/B Quality Control Kit
  • Modelo / Serial
    Lot Numbers: 51222E, 60121H, 60201D, and 60229F
  • Clasificación del producto
    Immunology and Microbiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Distributed in the states of: TX, NY, OR, HI, MD, PA, NC, MA, IA, WA, OR, AK, ME, MN, VA, MT, PA, and LA.
  • Descripción del producto
    cobas¿ Liat Influenza A/B Quality Control Kit; For use with cobas¿ Liat Influenza A/B Assay.
  • Manufacturer
    Roche Molecular Systems, Inc.
Device Recall Roche cobas p312 preanalytical system
  • Modelo / Serial
    Not applicable
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    US Nationwide Distribution
  • Descripción del producto
    cobas p 312 Pre-Analytical System || calculator/data processing module, for clinical use || Product Usage: || The cobas p471 system is an automatic centrifuge module for centrifuging primary sample tubes, which will then be transported to the output module.
  • Manufacturer
    Roche Diagnostics Operations, Inc.
Device Recall Roche cobas p471 system
  • Modelo / Serial
    Not applicable
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    US Nationwide Distribution
  • Descripción del producto
    cobas p 471 centrifuge unit || calculator/data processing module, for clinical use || Product Usage: || The cobas p312 pre-analytical system is a computer controlled stand-alone system for sorting and decapping sample tubes. As an option, the system works with an online connection.
  • Manufacturer
    Roche Diagnostics Operations, Inc.
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