BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    cobas® HBV

    DI: 00875197006414 · Model: 09040820190 · Roche Molecular Systems, Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    cobas® HBV
    Primary DI
    00875197006414
    Version / Model
    09040820190
    Catalog Number
    09040820190
    Company Name
    Roche Molecular Systems, Inc.
    Labeler DUNS
    071674100
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2021-12-10
    Public Version
    1
    Public Version Date
    2021-12-22
    Public Version Status
    New
    Public Device Record Key
    16837564-e345-491e-9f92-63bcac607c32

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    Yes
    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
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    No
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    MKT Hepatitis Viral B DNA Detection

    GMDN Terms

    Code Name
    48307 Hepatitis B virus nucleic acid IVD, kit, nucleic acid technique (NAT)

    Identifiers

    Type ID
    Primary 00875197006414