BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    New Life Diagnostics

    DI: 00850078606242 · Model: Leishmania IgM ELISA Kit · NEW LIFE DIAGNOSTICS LLC
    View on AccessGUDID
    Product Codes
    0
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    New Life Diagnostics
    Primary DI
    00850078606242
    Version / Model
    Leishmania IgM ELISA Kit
    Catalog Number
    5020
    Company Name
    NEW LIFE DIAGNOSTICS LLC
    Labeler DUNS
    081986839
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2026-04-16
    Public Version
    1
    Public Version Date
    2026-04-24
    Public Version Status
    New
    Public Device Record Key
    f56778f2-f729-4af5-af9f-5730efa12a74

    Device Characteristics

    Single Use
    Yes
    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
    Yes
    PM Exempt
    Yes
    Has Serial Number
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    Yes
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    GMDN Terms

    Code Name
    51098 Multiple Leptospira species immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)

    Identifiers

    Type ID
    Primary 00850078606242