Device Recall Amplilink

Manufacturer

  • Manufacturer Address
    Roche Molecular Systems, Inc., 1080 US Highway 202 S, Somerville NJ 08876-3733
  • Source
    USFDA

3 devices with a similar name

Learn more about the data here

  • Model / Serial
    Device-associated diagnostic software
  • Product Classification
  • Device Class
    Unclassified
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution
  • Product Description
    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
  • Model / Serial
    Catalog number 03576710190, working substrate SB3-SB
  • Product Classification
  • Device Class
    3
  • Implanted device?
    No
  • Distribution
    Nationwide to hospitals and laboratories.
  • Product Description
    Amplilink Software Versions 1.1, 1.3, 1.4, 2.41 || COBAS AmpliPrep/COBAS Amplicor HCV Test, version 2.0
  • Manufacturer
  • Model / 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.
  • Product Classification
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution
  • Product Description
    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