Devices

Device Recall AMPLILINK

  • Modelo / Serial
    Device-associated diagnostic software
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    Unclassified
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution
  • Descripción del producto
    Data Station AMPLILINK software is an instrument user interface/ data management software used with COBAS¿ AmpliPrep instrument, COBAS¿ TaqMan¿ analyzer, COBAS¿ TaqMan¿ 48 analyzer, COBAS¿ AMPLICOR¿ analyzer, and Cobas p 630 instrument for sample preparation, amplification and detection of PCR (Polymerase Chain Reaction) molecular diagnostic analytes.
  • 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

3 dispositivos con un nombre similar

Más información acerca de la data acá

Device Recall Amplilink
  • Modelo / Serial
    Catalog number 20757497122, working probe suspension /IC PS1-IC4; Catalog Number 20757535122, Working substrate SB3-SB
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Nationwide to hospitals and laboratories.
  • Descripción del producto
    Amplilink Software versions 1.1, 1.3, 1.4, 2.41. || COBAS Amplicor CTA & NGA Tests
  • Manufacturer
    Roche Molecular Systems, Inc.
Device Recall Amplilink
  • Modelo / Serial
    Catalog number 03576710190, working substrate SB3-SB
  • Clasificación del producto
    Immunology and Microbiology Devices
  • Clase de dispositivo
    3
  • ¿Implante?
    No
  • Distribución
    Nationwide to hospitals and laboratories.
  • Descripción del producto
    Amplilink Software Versions 1.1, 1.3, 1.4, 2.41 || COBAS AmpliPrep/COBAS Amplicor HCV Test, version 2.0
  • Manufacturer
    Roche Molecular Systems, Inc.
Device Recall AMPLILINK Software, version 3.1.0 to 3.2.2
  • Modelo / Serial
    Version 3.1.0, Version 3.1.1, Version 3.1.2, Version 3.2.0, Version 3.2.1, and Version 3.2.2.
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution
  • Descripción del producto
    AMPLILINK Software, version 3.1.0 to 3.2.2 with COBAS AmpliPrep. Catalog number 03563383001, catalog number 04855094001, catalog number 04807197001, catalog number 04862392001, catalog number 05093236001, and catalog number 05201357001. || Automated sample preparation for nucleic acid analysis on either the COBAS TaqMan or COBAS TaqMan 48. COBAS AmpliPrep/COBAS TaqMan is capable of tunning HBV, HCV, and HIV tests.
  • Manufacturer
    Roche Molecular Systems, Inc.