BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    CDS-LTX CONTROL

    DI: 00812137010254 · Model: 6 x 16 mL · CLINICAL DIAGNOSTIC SOLUTIONS, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    6

    Basic Information

    Brand Name
    CDS-LTX CONTROL
    Primary DI
    00812137010254
    Version / Model
    6 x 16 mL
    Catalog Number
    502-006
    Company Name
    CLINICAL DIAGNOSTIC SOLUTIONS, INC.
    Labeler DUNS
    048144997
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    6
    Record Status
    Published
    Publish Date
    2016-09-08
    Public Version
    3
    Public Version Date
    2018-07-06
    Public Version Status
    Update
    Public Device Record Key
    1d5a7200-7d5d-4cda-9a8d-6faa743dac5f

    Device Description

    CDS-LTX Control is used to validate volume, conductivity and light scatter parameters on COULTER HmX/ MAXM, STKS and GEN-S instruments. Prepare instrument with CDS LTX Primer immediately prior to CDS-LTX Control measurements. Accurate differential and reticulocyte measurements on COULTER HmX/MAXM, STKS and GEN-S instruments are assured by demonstrating consistent performance of volume, conductivity and light scatter parameters, using a particle of uniform size with appropriate light scattering characteristics. CDS-LTX Control validates the stability of the electrical processing and fluidic flow rate systems used to measure volume, conductivity and light scatter.

    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
    Yes
    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
    KRX Calibrator For Cell Indices

    GMDN Terms

    Code Name
    30537 Reticulocyte count IVD, control

    Identifiers

    Type ID
    Primary 00812137010254
    Unit of Use 00812137011824

    Customer Contacts

    Phone
    8004533328
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K993375 000

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    2 – 10 Degrees Celsius