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    FDA UDI In Commercial Distribution 🇺🇸 United States

    Elecsys AFP

    DI: 07613336206157 · Model: 09015060160 · Roche Diagnostics GmbH
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    Elecsys AFP
    Primary DI
    07613336206157
    Version / Model
    09015060160
    Catalog Number
    09015060160
    Company Name
    Roche Diagnostics GmbH
    Labeler DUNS
    315028860
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2022-12-06
    Public Version
    1
    Public Version Date
    2022-12-14
    Public Version Status
    New
    Public Device Record Key
    2a950278-d66e-4dd6-9fd0-5a7242291a70

    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
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    LOJ KIT, TEST,ALPHA-FETOPROTEIN FOR TESTICULAR CANCER

    GMDN Terms

    Code Name
    58348 Alpha-fetoprotein (AFP) IVD, kit, chemiluminescent immunoassay

    Identifiers

    Type ID
    Primary 07613336206157

    Premarket Submissions

    Submission Number Supplement Number
    K220176 000