BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Dipper Urinalysis Dipstick Control Level 1&2 Set 6x15mL

    DI: 00896863002134 · Model: 1440-01 · QUANTIMETRIX CORPORATION
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Dipper Urinalysis Dipstick Control Level 1&2 Set 6x15mL
    Primary DI
    00896863002134
    Version / Model
    1440-01
    Catalog Number
    1440-01
    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
    823a41f1-6f46-4075-9ccf-d6d750e0bc6c

    Device Description

    The Dipper Urinalysis Dipstick Control is intended as a control for urinalysis reagent strips, microalbumin, and creatinine by the listed test methods, and as a control for confirmatory tests. They are supplied in two levels as 6x15mL, three tubes of each level or 6x15mL level 2 only. They are liquid, ready-to-use requiring no reconstitution or dilution. They are prepared from human urine fortified to target levels with compounds that produce the desired reaction when tested by the methods indicated in the product insert. Preservatives have been added to inhibit microbial growth.

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    No
    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
    JJW Urinalysis Controls (Assayed And Unassayed)

    GMDN Terms

    Code Name
    30219 Multiple urine analyte IVD, control

    Identifiers

    Type ID
    Primary 00896863002134
    Secondary M0511440011

    Customer Contacts

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

    Premarket Submissions

    Submission Number Supplement Number
    K874890 000

    Storage Conditions

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