BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    DHEA-S-7 RIA

    DI: 15099590211509 · Model: DSL2700 · IMMUNOTECH s.r.o.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    DHEA-S-7 RIA
    Primary DI
    15099590211509
    Version / Model
    DSL2700
    Catalog Number
    DSL2700
    Company Name
    IMMUNOTECH s.r.o.
    Labeler DUNS
    360561849
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2023-07-06
    Public Version
    1
    Public Version Date
    2023-07-14
    Public Version Status
    New
    Public Device Record Key
    59bc44d7-96c3-4eed-b122-850112ca6df0

    Device Description

    DHEA-S-7 RIA

    Device Characteristics

    Single Use
    No
    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
    Yes
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    JKC Radioimmunoassay, Dehydroepiandrosterone (Free And Sulfate)

    GMDN Terms

    Code Name
    58374 Dehydroepiandrosterone sulfate (DHEAS) IVD, kit, radioimmunoassay

    Identifiers

    Type ID
    Primary 15099590211509

    Premarket Submissions

    Submission Number Supplement Number
    K962895 000