Devices

Cobas

  • Model / Serial
    Lot #s: 70712A (6 kits); 70601W (76 kits); 70713A (4 kits); 70718A (50 kits); and 70809A (kits were not distributed to end users).
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide distribution. Austria, Denmark, Germany, Singapore, Netherlands, Hong Kong, and Switzerland. US product is not affected.
  • Product Description
    Nucleic Acid test intended for screening for MRSA/SA. Each kit has 20 tubes. in vitro diagnostic.
  • Manufacturer
    Roche Molecular Systems, Inc.
  • 1 Event

Manufacturer

Roche Molecular Systems, Inc.
  • Manufacturer Address
    Roche Molecular Systems, Inc., 1080 US Highway 202 S, Branchburg NJ 08876-3733
  • Manufacturer Parent Company (2017)
    Roche Holding AG
  • Source
    USFDA

918 devices with a similar name

Learn more about the data here

COBAS AmpliPrep Instrument
COBAS INTEGRA IGGT
  • Model / Serial
    20766631322
  • Product Description
    IVD: Reagent, immunoglobulin G
  • Manufacturer
    Roche Diagnostics GmbH
cobas c pack VANC2
  • Model / Serial
    04491050 190 | all
  • Product Description
    IVD: Vancomycin kit
  • Manufacturer
    Roche Diagnostics GmbH
cobas c pack VALP2
  • Model / Serial
    04491041 190 | all
  • Product Description
    IVD: Valproic acid kit
  • Manufacturer
    Roche Diagnostics GmbH
Cobas Integra analyzer
  • Model / Serial
  • Product Description
    IVD: Clinical chemistry calibrator, multi-component Assayed multicomponent serum kit, normal Assayed multicomponent serum kit, abnormal Analyser, clinical chemistry
  • Manufacturer
    Roche Diagnostics GmbH
913 more