BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Oral Fluid Amphetamine Enzyme Immunoassay

    DI: B076S0041B0 · Model: S0041b · LIN-ZHI INTERNATIONAL, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Oral Fluid Amphetamine Enzyme Immunoassay
    Primary DI
    B076S0041B0
    Version / Model
    S0041b
    Catalog Number
    S0041b
    Company Name
    LIN-ZHI INTERNATIONAL, INC.
    Labeler DUNS
    840839190
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-07-05
    Public Version
    4
    Public Version Date
    2018-08-23
    Public Version Status
    Update
    Public Device Record Key
    fa59b3b7-9dd0-4704-b1c7-007379206897

    Device Description

    Large Test Kit. Antibody/Substrate Reagent (R1): 750 mL. Enzyme Conjugate Reagent (R2): 375 mL.

    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
    DKZ Enzyme Immunoassay, Amphetamine

    GMDN Terms

    Code Name
    55493 Amphetamine-specific IVD, kit, enzyme immunoassay (EIA)

    Identifiers

    Type ID
    Primary B076S0041B0

    Premarket Submissions

    Submission Number Supplement Number
    K131653 000

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    2 – 8 Degrees Celsius