BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    K-CHECK CONTROLS

    DI: 00860009154025 · Model: 1 · Biorex Labs LLC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    K-CHECK CONTROLS
    Primary DI
    00860009154025
    Version / Model
    1
    Catalog Number
    B1777
    Company Name
    Biorex Labs LLC
    Labeler DUNS
    060975106
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2022-12-02
    Public Version
    1
    Public Version Date
    2022-12-12
    Public Version Status
    New
    Public Device Record Key
    3c08d985-5e2e-4197-8bc9-17d3ff57da6c

    Device Description

    The K-CHECK Controls are intended to be used by trained laboratory professionals to evaluate and verify the expected accuracy and performance of K-CHECK Reagent tablets. The set of three controls consist of Levels 0, 1 and 2. The matrix used to manufacture the controls is a synthetic serum-like matrix and therefore free of potential infectious agents. The results are read visually by comparing to the color chart provided in the product insert. An opened vial is good for 30 days. An unopened vial has an expiration of one year.

    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
    No
    Has Manufacturing Date
    No
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    JJX Single (Specified) Analyte Controls (Assayed And Unassayed)

    GMDN Terms

    Code Name
    55470 Acetone IVD, control

    Identifiers

    Type ID
    Primary 00860009154025

    Customer Contacts

    Phone
    440-824-3000
    Email
    [email protected]

    Storage Conditions

    Type
    Special Storage Condition, Specify
    Special Conditions
    Refrigerate between 2-10 degrees Celsius (°C)