BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    COBAS® AmpliPrep Instrument

    DI: 04015630924615 · Model: 03051315001 · Roche Molecular Systems, Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    COBAS® AmpliPrep Instrument
    Primary DI
    04015630924615
    Version / Model
    03051315001
    Catalog Number
    03051315001
    Company Name
    Roche Molecular Systems, Inc.
    Labeler DUNS
    071674100
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2014-09-15
    Public Version
    2
    Public Version Date
    2018-03-29
    Public Version Status
    Update
    Public Device Record Key
    2abbe4fa-cbef-4211-a2dd-7ab7df129302

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    No
    Over the Counter (OTC)
    No
    Kit
    No
    Combination Product
    No
    HCT/P
    No
    Contains NRL
    No
    Not Made with NRL
    No
    MRI Safety
    Labeling does not contain MRI Safety Information
    Direct Marking Exempt
    No
    PM Exempt
    No
    Has Serial Number
    Yes
    Has Lot/Batch Number
    No
    Has Manufacturing Date
    Yes
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    JJH CLINICAL SAMPLE CONCENTRATOR

    GMDN Terms

    Code Name
    60737 Nucleic acid sample preparation instrument IVD, semi-automated

    Identifiers

    Type ID
    Primary 04015630924615