BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    COBAS® AmpliScreen HBV Test

    DI: 00875197002102 · Model: 03599779190 · Roche Molecular Systems, Inc.
    View on AccessGUDID
    Product Codes
    0
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    COBAS® AmpliScreen HBV Test
    Primary DI
    00875197002102
    Version / Model
    03599779190
    Catalog Number
    03599779190
    Company Name
    Roche Molecular Systems, Inc.
    Labeler DUNS
    071674100
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2014-09-17
    Public Version
    3
    Public Version Date
    2026-04-13
    Public Version Status
    Update
    Public Device Record Key
    670e7bfe-bbe5-4807-a4ff-17e1f175fd5c

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    No
    Over the Counter (OTC)
    No
    Kit
    Yes
    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
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    GMDN Terms

    Code Name
    48216 Multiple blood-borne virus nucleic acid IVD, kit, nucleic acid technique (NAT)

    Identifiers

    Type ID
    Primary 00875197002102