BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    SCoV-2 Detect™ IgM ELISA

    DI: B379COVEM1 · Model: COVE-M · INBIOS INTERNATIONAL, INC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    SCoV-2 Detect™ IgM ELISA
    Primary DI
    B379COVEM1
    Version / Model
    COVE-M
    Company Name
    INBIOS INTERNATIONAL, INC
    Labeler DUNS
    004006628
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2022-12-08
    Public Version
    1
    Public Version Date
    2022-12-16
    Public Version Status
    New
    Public Device Record Key
    06079dec-0167-4518-abe4-4cddaba5add8

    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

    Product Codes

    Code Name
    QKO Reagent, Coronavirus Serological

    GMDN Terms

    Code Name
    64800 SARS-CoV-2 immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)

    Identifiers

    Type ID
    Primary B379COVEM1