BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Pointe Fentanyl (Qualitative) Reagent Set

    DI: 00811727016409 · Model: 60-FN0620-100 · HORIBA INSTRUMENTS INCORPORATED
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    Pointe Fentanyl (Qualitative) Reagent Set
    Primary DI
    00811727016409
    Version / Model
    60-FN0620-100
    Catalog Number
    60-FN0620-100
    Company Name
    HORIBA INSTRUMENTS INCORPORATED
    Labeler DUNS
    052845583
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2020-09-25
    Public Version
    2
    Public Version Date
    2025-10-02
    Public Version Status
    Update
    Public Device Record Key
    14ea9dd8-512d-492b-8a90-e1be5662a883

    Device Description

    Pointe Fentanyl (Qualitative) Reagent Set 1 x 100 mL R1, 1 x 37.5 mL R2 The Pointe Fentanyl Reagent Set is intended for the qualitative determination of norfentanyl in human urine at the cutoff value of 5 ng/mL when calibrated against norfentanyl. The assay is designed for prescription use with a number of automated clinical chemistry analyzers.

    Device Characteristics

    Single Use
    No
    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 00811727016409

    Customer Contacts

    Phone
    800-445-9853
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K181159 000

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    2 – 8 Degrees Celsius