BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Multi-Analyte DAU Control Set E, Level 1 Control

    DI: B07608970 · Model: 0897 · LIN-ZHI INTERNATIONAL, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    Multi-Analyte DAU Control Set E, Level 1 Control
    Primary DI
    B07608970
    Version / Model
    0897
    Catalog Number
    0897
    Company Name
    LIN-ZHI INTERNATIONAL, INC.
    Labeler DUNS
    840839190
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2019-03-26
    Public Version
    1
    Public Version Date
    2019-04-03
    Public Version Status
    New
    Public Device Record Key
    bb7d363f-52d9-4508-9bff-c4567154f6d3

    Device Description

    15 mL/bottle. Concentration of Multi-Analyte: 150 ng/mL secobarbital, 7 ng/mL norbuprenorphine, 225 ng/mL methadone, and 18 ng/mL phencyclidine.

    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
    Yes
    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
    DIF Drug Mixture Control Materials

    GMDN Terms

    Code Name
    55461 Multiple drugs of abuse IVD, control

    Identifiers

    Type ID
    Primary B07608970

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    2 – 8 Degrees Celsius