BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    qUAntify

    DI: 03610522007981 · Model: 12007028 · BIO-RAD LABORATORIES, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    qUAntify
    Primary DI
    03610522007981
    Version / Model
    12007028
    Catalog Number
    12007028
    Company Name
    BIO-RAD LABORATORIES, INC.
    Labeler DUNS
    051624070
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2020-09-14
    Public Version
    2
    Public Version Date
    2023-01-31
    Public Version Status
    Update
    Public Device Record Key
    bdb8be5e-0c65-4878-96a5-187916076c26

    Device Description

    qUAntify Advance Control Bilevel (A liquid urinalysis control.)

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    No
    Over the Counter (OTC)
    No
    Kit
    No
    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
    JJW Urinalysis controls (assayed and unassayed)

    GMDN Terms

    Code Name
    30219 Multiple urine analyte IVD, control

    Identifiers

    Type ID
    Primary 03610522007981

    Customer Contacts

    Phone
    +1(800)854-6737
    Email
    [email protected]

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    2 – 8 Degrees Celsius