BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    STATTEST Home Pregnancy Test

    DI: 00816036025968 · Model: STP-10-0 · MICRO DISTRIBUTING, L.C
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    STATTEST Home Pregnancy Test
    Primary DI
    00816036025968
    Version / Model
    STP-10-0
    Catalog Number
    STP-10-0
    Company Name
    MICRO DISTRIBUTING, L.C
    Labeler DUNS
    087732173
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2020-06-18
    Public Version
    2
    Public Version Date
    2023-07-06
    Public Version Status
    Update
    Public Device Record Key
    13640463-d1d9-4172-bdb3-74d4f10f319e

    Device Description

    Single STATDIP Pregnancy Midstream 10 mIU/mL, 1 Test per Box

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    Yes
    Over the Counter (OTC)
    Yes
    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
    LCX Kit, Test, Pregnancy, Hcg, Over The Counter
    JHI Visual, Pregnancy Hcg, Prescription Use

    GMDN Terms

    Code Name
    33819 Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical

    Identifiers

    Type ID
    Primary 00816036025968