BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    ARK™ Fentanyl II Assay

    DI: 00812101030578 · Model: 5069-0001-01 · ARK DIAGNOSTICS INC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    ARK™ Fentanyl II Assay
    Primary DI
    00812101030578
    Version / Model
    5069-0001-01
    Catalog Number
    5069-0001-01
    Company Name
    ARK DIAGNOSTICS INC
    Labeler DUNS
    164880598
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2020-02-27
    Public Version
    1
    Public Version Date
    2020-03-06
    Public Version Status
    New
    Public Device Record Key
    1cc57c7d-b6e6-4f6a-a8b7-a03a937679b1

    Device Description

    The ARK™ Fentanyl II Assay is an immunoassay intended for the qualitative detection of fentanyl in human urine at a cutoff concentration of 1.0 ng/mL.

    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
    DJG Enzyme Immunoassay, Opiates

    GMDN Terms

    Code Name
    63018 Fentanyl IVD, kit, enzyme immunoassay (EIA)

    Identifiers

    Type ID
    Primary 00812101030578

    Customer Contacts

    Phone
    5102706270
    Email
    [email protected]

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    2 – 8 Degrees Celsius