BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    AMP Rapid Test Cassette

    DI: 00853691007113 · Model: 1 · ACRO BIOTECH INC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    AMP Rapid Test Cassette
    Primary DI
    00853691007113
    Version / Model
    1
    Company Name
    ACRO BIOTECH INC
    Labeler DUNS
    079697380
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2017-06-28
    Public Version
    2
    Public Version Date
    2018-03-29
    Public Version Status
    Update
    Public Device Record Key
    a4c9ea8d-9ee7-44d6-bfe7-0f13e16d18c8

    Device Description

    AMP Rapid Test Cassette

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    No
    Over the Counter (OTC)
    No
    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
    DKZ Enzyme Immunoassay, Amphetamine

    GMDN Terms

    Code Name
    55493 Amphetamine-specific IVD, kit, enzyme immunoassay (EIA)

    Identifiers

    Type ID
    Primary 00853691007113