BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Sweat Controls, L1, L2, L3, 12 ea., 36x0.75mL

    DI: 03661540304361 · Model: SS-150 · ELITECHGROUP INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    Sweat Controls, L1, L2, L3, 12 ea., 36x0.75mL
    Primary DI
    03661540304361
    Version / Model
    SS-150
    Company Name
    ELITECHGROUP INC.
    Labeler DUNS
    052423787
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2020-10-16
    Public Version
    1
    Public Version Date
    2020-10-26
    Public Version Status
    New
    Public Device Record Key
    35947a09-66d3-4b1c-a4fa-baff43502b52

    Device Description

    ELITechGroup Sweat Controls for Cystic Fibrosis Testing are assayed controls intended as a means of validating the measurement of conductivity , osmolality, or chloride in patient samples.

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

    GMDN Terms

    Code Name
    52878 Chloride (Cl-) IVD, control

    Identifiers

    Type ID
    Primary 03661540304361

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    15 – 25 Degrees Celsius