BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Speedy Tests

    DI: 10866415000311 · Model: STDIPMA-25 · SPEEDY SOLUTIONS LLC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    25

    Basic Information

    Brand Name
    Speedy Tests
    Primary DI
    10866415000311
    Version / Model
    STDIPMA-25
    Catalog Number
    STDIPMA-25
    Company Name
    SPEEDY SOLUTIONS LLC
    Labeler DUNS
    080428145
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    25
    Record Status
    Published
    Publish Date
    2017-03-09
    Public Version
    2
    Public Version Date
    2018-03-29
    Public Version Status
    Update
    Public Device Record Key
    204b5b0d-34b5-4886-95f5-eb68f31b7af8

    Device Description

    Speedy Tests DOA Single Test Dipcard, 25Pcs/Box mAMP

    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
    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
    DJC Thin Layer Chromatography, Methamphetamine

    GMDN Terms

    Code Name
    55334 Disopyramide therapeutic drug monitoring IVD, calibrator

    Identifiers

    Type ID
    Primary 10866415000311
    Unit of Use 00866415000314