BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    One Step FSH Urine midstream Test

    DI: 06936983131018 · Model: 1 · Hangzhou AllTest Biotech Co., Ltd.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    2

    Basic Information

    Brand Name
    One Step FSH Urine midstream Test
    Primary DI
    06936983131018
    Version / Model
    1
    Company Name
    Hangzhou AllTest Biotech Co., Ltd.
    Labeler DUNS
    543254717
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    2
    Record Status
    Published
    Publish Date
    2025-08-29
    Public Version
    3
    Public Version Date
    2025-09-23
    Public Version Status
    Update
    Public Device Record Key
    7268689a-af97-4b08-b900-4d88ae436a2f

    Device Description

    One Step FSH Urine midstream Test, EN, 2T

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    No
    Over the Counter (OTC)
    Yes
    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
    Yes
    Has Serial Number
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    No
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    NGA Test, Follicle Stimulating Hormone (Fsh), Over The Counter

    GMDN Terms

    Code Name
    65840 Follicle stimulating hormone (FSH) IVD, kit, rapid ICT, clinical

    Identifiers

    Type ID
    Primary 06936983131018
    Unit of Use 86936983131014