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

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Roche/Hitachi cobas ONLINE TDM Gentamicin
  • Model / Serial
    Lot Numbers 15617800, 15622600, 15616900 and 15621900.
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution.
  • Product Description
    Roche/Hitachi cobas ONLINE TDM Gentamicin for Roche analyzer models 911, 912, 917 and Modular P; Catalog no. 03800504190. || The product is used for in vitro diagnostic reagent for the quantitative determination of gentamicin in human serum or plasma on automated clinical chemistry analyzers.
  • Manufacturer
    Roche Diagnostics Operations, Inc.
Roche/Hitachi cobas ONLINE TDM Gentamicin
  • Model / Serial
    Lot Numbers 15622600, 15617800, 15616900 and 15816200.
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution.
  • Product Description
    Roche/Hitachi cobas ONLINE TDM Gentamicin for Roche analyzer models 917 and Modular P; Catalog no. 03500241190. || The product is used for in vitro diagnostic reagent for the quantitative determination of gentamicin in human serum or plasma on automated clinical chemistry analyzers.
  • Manufacturer
    Roche Diagnostics Operations, Inc.
Roche/Hitachi cobas GENT2 ONLINE TDM Gentamicin
  • Model / Serial
    Lot Numbers 15621900, 15617800, 15622600, 15616900, 15816200 and 15815600.
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution.
  • Product Description
    Roche/Hitachi GENT2 ONLINE TDM Gentamicin for Roche cobas c 501 analyzer systems; Catalog no. 04490843190. || The product is used for in vitro diagnostic reagent for the quantitative determination of gentamicin in human serum or plasma on automated clinical chemistry analyzers.
  • Manufacturer
    Roche Diagnostics Operations, Inc.
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