BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    ARK™ Gabapentin Assay (c-pack)

    DI: 00858724003261 · Model: 5025-0001-01 · ARK DIAGNOSTICS INC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    ARK™ Gabapentin Assay (c-pack)
    Primary DI
    00858724003261
    Version / Model
    5025-0001-01
    Catalog Number
    5025-0001-01
    Company Name
    ARK DIAGNOSTICS INC
    Labeler DUNS
    164880598
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-09-24
    Public Version
    4
    Public Version Date
    2021-03-02
    Public Version Status
    Update
    Public Device Record Key
    b2d57fa9-1a57-42a4-8886-275fcbf446a6
    Distribution End Date
    2021-03-01

    Device Description

    The ARK™ Gabapentin Assay is a homogeneous enzyme immunoassay intended for the quantitative determination of gabapentin in human serum or plasma on automated clinical chemistry analyzers. Gabapentin concentrations can be used as an aid in management of patients treated with gabapentin.

    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
    OTF Gabapentin Assay

    GMDN Terms

    Code Name
    55709 Neurontin (gabapentin) IVD, reagent

    Identifiers

    Type ID
    Primary 00858724003261

    Customer Contacts

    Phone
    5102706270
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K101574 000

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    2 – 8 Degrees Celsius