BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Dropper Urine Chemistry Control Level 1 Set 3x10mL

    DI: 00896863002196 · Model: 1431-31 · QUANTIMETRIX CORPORATION
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Dropper Urine Chemistry Control Level 1 Set 3x10mL
    Primary DI
    00896863002196
    Version / Model
    1431-31
    Catalog Number
    1431-31
    Company Name
    QUANTIMETRIX CORPORATION
    Labeler DUNS
    010717890
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2018-09-26
    Public Version
    1
    Public Version Date
    2018-10-29
    Public Version Status
    New
    Public Device Record Key
    7917150e-fdfb-4740-89bd-062dce2aa898

    Device Description

    The Dropper Urine Chemistry Control is intended for use as a control for human urine assay methods. It is supplied as a ready-to-use liquid requiring no reconstitution. They are prepared from human urine and fortified to target levels with human proteins and reagent grade chemicals. Preservatives have been added to inhibit microbial growth.

    Device Characteristics

    Single Use
    No
    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
    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
    JJW Urinalysis Controls (Assayed And Unassayed)

    GMDN Terms

    Code Name
    30219 Multiple urine analyte IVD, control

    Identifiers

    Type ID
    Primary 00896863002196
    Secondary M0511431311

    Customer Contacts

    Phone
    (310) 536-0006
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K831526 000

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    2 – 8 Degrees Celsius
    Type
    Handling Environment Temperature
    Temperature Range
    18 – 25 Degrees Celsius