BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Alltest TCA1000 Home Rapid Test Panel (Urine)

    DI: 06936983114646 · Model: 1 · Hangzhou AllTest Biotech Co., Ltd.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    Alltest TCA1000 Home Rapid Test Panel (Urine)
    Primary DI
    06936983114646
    Version / Model
    1
    Catalog Number
    DTC-A114H (1000ng)
    Company Name
    Hangzhou AllTest Biotech Co., Ltd.
    Labeler DUNS
    543254717
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2026-04-21
    Public Version
    1
    Public Version Date
    2026-04-29
    Public Version Status
    New
    Public Device Record Key
    dac6ef17-553c-478b-9bd0-d0266c1c52de

    Device Description

    1T, for FDA

    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
    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
    QAW Test, Tricyclic Antidepressants, Over The Counter

    GMDN Terms

    Code Name
    55712 Nortriptyline IVD, reagent

    Identifiers

    Type ID
    Primary 06936983114646