BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    ZIKV Detect™ 2.0 IgM Capture ELISA

    DI: B379ZKM21 · Model: IVD · INBIOS INTERNATIONAL, INC
    View on AccessGUDID
    Product Codes
    0
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    ZIKV Detect™ 2.0 IgM Capture ELISA
    Primary DI
    B379ZKM21
    Version / Model
    IVD
    Company Name
    INBIOS INTERNATIONAL, INC
    Labeler DUNS
    004006628
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2019-05-24
    Public Version
    1
    Public Version Date
    2019-06-03
    Public Version Status
    New
    Public Device Record Key
    4a9c5081-d188-4579-846f-f7b2b26f2dba

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    Yes
    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
    49106 Zika virus immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)

    Identifiers

    Type ID
    Primary B379ZKM21