BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Fentanyl II Enzyme Immunoassay

    DI: 00850624008261 · Model: 09444360190 · LIN-ZHI INTERNATIONAL, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Fentanyl II Enzyme Immunoassay
    Primary DI
    00850624008261
    Version / Model
    09444360190
    Catalog Number
    09444360190
    Company Name
    LIN-ZHI INTERNATIONAL, INC.
    Labeler DUNS
    840839190
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2021-10-26
    Public Version
    2
    Public Version Date
    2022-08-12
    Public Version Status
    Update
    Public Device Record Key
    47443a5a-a38d-4868-8c94-364fb282c93c

    Device Description

    240 tests. c pack green, PCh Antibody/Substrate Reagent (R1): 1 x 24.0 mL Enzyme Conjugate Reagent (R2): 1 x 10.1 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 00850624008261

    Premarket Submissions

    Submission Number Supplement Number
    K201938 000

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    2 – 8 Degrees Celsius