BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    CERTUM One Step Multi-Drug Screen Panel

    DI: 00810124273835 · Model: DOA-164-141-a · Alere San Diego, Inc.
    View on AccessGUDID
    Product Codes
    6
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    25

    Basic Information

    Brand Name
    CERTUM One Step Multi-Drug Screen Panel
    Primary DI
    00810124273835
    Version / Model
    DOA-164-141-a
    Catalog Number
    4566591326
    Company Name
    Alere San Diego, Inc.
    Labeler DUNS
    194854949
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    25
    Record Status
    Published
    Publish Date
    2024-12-17
    Public Version
    2
    Public Version Date
    2026-03-13
    Public Version Status
    Update
    Public Device Record Key
    67af33be-ec47-49e0-be43-b99afbce0087

    Device Description

    COC300/AMP1000/mAMP1000/THC50/OPI2000/BZO300

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    Yes
    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
    DIO Enzyme Immunoassay, Cocaine And Cocaine Metabolites
    DKZ Enzyme Immunoassay, Amphetamine
    DJC Thin Layer Chromatography, Methamphetamine
    LDJ Enzyme Immunoassay, Cannabinoids
    DJG Enzyme Immunoassay, Opiates
    JXM Enzyme Immunoassay, Benzodiazepine

    GMDN Terms

    Code Name
    46994 Multiple drugs of abuse IVD, kit, rapid ICT, clinical

    Identifiers

    Type ID
    Unit of Use 10810124273832
    Primary 00810124273835