BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    SAS hCG Urine Control Set

    DI: 00780311000486 · Model: 087413 · SA SCIENTIFIC, LTD.
    View on AccessGUDID
    Product Codes
    0
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    SAS hCG Urine Control Set
    Primary DI
    00780311000486
    Version / Model
    087413
    Company Name
    SA SCIENTIFIC, LTD.
    Labeler DUNS
    122092117
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2018-11-01
    Public Version
    2
    Public Version Date
    2023-07-06
    Public Version Status
    Update
    Public Device Record Key
    75931279-596e-4daa-9128-4b91e73d0a01

    Device Description

    SAS™ hCG Urine Controls are intended to be used to monitor the performance and accuracy of SAS™ Urine hCG pregnancy test kits. These controls are for professional use only.

    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
    Yes
    Has Lot/Batch Number
    No
    Has Manufacturing Date
    No
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    GMDN Terms

    Code Name
    38262 Total human chorionic gonadotropin IVD, control

    Identifiers

    Type ID
    Primary 00780311000486