BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    Scantibodies Laboratory, Inc.

    DI: 00850002253115 · Model: 3KG056 · SCANTIBODIES LABORATORY, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Scantibodies Laboratory, Inc.
    Primary DI
    00850002253115
    Version / Model
    3KG056
    Company Name
    SCANTIBODIES LABORATORY, INC.
    Labeler DUNS
    087577680
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2019-05-20
    Public Version
    3
    Public Version Date
    2023-01-31
    Public Version Status
    Update
    Public Device Record Key
    be0318a4-54e3-408f-b475-d49cb6710f1b
    Distribution End Date
    2021-03-31

    Device Description

    Whole PTH (1-84) Specific IRMA (Coated Bead)

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    No
    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
    CEW Radioimmunoassay, Parathyroid Hormone

    GMDN Terms

    Code Name
    54279 Parathyroid hormone (PTH) IVD, kit, enzyme immunoassay (EIA)

    Identifiers

    Type ID
    Primary 00850002253115