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    FDA UDI In Commercial Distribution 🇺🇸 United States

    Teco Diagnostics TC-Thunderbolt Automated Urine Analyzer System

    DI: 10673486000528 · Model: TC-Thunderbolt · TECO DIAGNOSTICS
    View on AccessGUDID
    Product Codes
    11
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    Teco Diagnostics TC-Thunderbolt Automated Urine Analyzer System
    Primary DI
    10673486000528
    Version / Model
    TC-Thunderbolt
    Catalog Number
    TC-Thunderbolt
    Company Name
    TECO DIAGNOSTICS
    Labeler DUNS
    185067774
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2024-06-06
    Public Version
    1
    Public Version Date
    2024-06-14
    Public Version Status
    New
    Public Device Record Key
    90843c4c-7745-49b9-84ff-98a03458e0a6

    Device Description

    Teco Diagnostics TC-Thunderbolt Automated Urine Analyzer System is an in vitro diagnostic device used to automate the urine chemistry analysis using TC-Thunderbolt URS-10 strips. It produces semi-quantitative results of glucose, protein, pH, bilirubin, blood, ketone, urobilinogen, nitrite, specific gravity, and leukocytes in urine. TC-Thunderbolt URS-10 strips are intended for use only with the TC-Thunderbolt Automated Urine Analyzer System; they are not intended for manual visual reading. This device is for clinical laboratory use only. This device is not for point-of-care use. These measurements are used to aid in the diagnosis of metabolic disorders, kidney function anomalies, urinary tract infections, and liver function.

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    Yes
    Over the Counter (OTC)
    No
    Kit
    No
    Combination Product
    Yes
    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
    Yes
    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
    JIR Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)
    JIL Method, Enzymatic, Glucose (Urinary, Non-Quantitative)
    JIO Blood, Occult, Colorimetric, In Urine
    KQO Automated Urinalysis System
    LJX Test, Urine Leukocyte
    JRE Refractometer For Clinical Use
    CEN Dye-Indicator, Ph (Urinary, Non-Quantitative)
    JMT Diazo (Colorimetric), Nitrite (Urinary, Non-Quant)
    JIN Nitroprusside, Ketones (Urinary, Non-Quant.)
    CDM Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.)
    JJB Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.)

    GMDN Terms

    Code Name
    35918 Urine analyser IVD, laboratory

    Identifiers

    Type ID
    Primary 10673486000528

    Customer Contacts

    Phone
    7144631111
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K141289 000

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    5 – 40 Degrees Celsius
    Type
    Handling Environment Humidity
    Temperature Range
    30 – 80 Percent (%) Relative Humidity