BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    DOA CONTROL 2

    DI: 05055273207903 · Model: DA3122 · RANDOX LABORATORIES LIMITED
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    DOA CONTROL 2
    Primary DI
    05055273207903
    Version / Model
    DA3122
    Catalog Number
    DA3122
    Company Name
    RANDOX LABORATORIES LIMITED
    Labeler DUNS
    227530649
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-09-24
    Public Version
    3
    Public Version Date
    2020-12-21
    Public Version Status
    Update
    Public Device Record Key
    5ddbbc35-559c-41b8-81a4-fa18243f4541

    Device Description

    The Randox Multidrug Control Level 2 is intended for use in the Quality Control of Methamphetamine, Barbiturates, Cocaine, Methadone and Opiates assays.

    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
    DIF Drug Mixture Control Materials
    LAS Drug Specific Control Materials

    GMDN Terms

    Code Name
    55461 Multiple drugs of abuse IVD, control

    Identifiers

    Type ID
    Primary 05055273207903

    Customer Contacts

    Phone
    +442894451070
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K092266 000
    K092268 000
    K092272 000
    K092274 000
    K113747 000
    K113751 000

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    2 – 8 Degrees Celsius
    Type
    Special Storage Condition, Specify
    Special Conditions
    Stable for 28 days at +2ºC to +8ºC once opened