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    FDA UDI In Commercial Distribution 🇺🇸 United States

    Teco Diagnostics Uritek TC-201 Urine Chemistry Test System

    DI: 10673486000511 · Model: TC-201 · 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 Uritek TC-201 Urine Chemistry Test System
    Primary DI
    10673486000511
    Version / Model
    TC-201
    Catalog Number
    TC-201
    Company Name
    TECO DIAGNOSTICS
    Labeler DUNS
    185067774
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2024-06-04
    Public Version
    1
    Public Version Date
    2024-06-12
    Public Version Status
    New
    Public Device Record Key
    f858f35b-bac3-4493-868b-10bfedbda2c5

    Device Description

    Teco Diagnostics Uritek TC-201 Urine Chemistry Test System consists of the Uritek TC-201 Urine Chemistry Analyzer and the Teco Diagnostics Urine Reagent (URS-10) Strips. The Uritek TC-201 urine analyzer is an automated, bench top instrument which is intended for point-of-care, in vitro diagnostic use only and is intended to be used together with the Teco Diagnostics Urine Reagent (URS-10) Strips as a system for semi-quantitative detection of Glucose, Bilirubin, Ketone, Specific Gravity, Blood, pH, Protein, Urobilinogen, Nitrite and Leukocytes in urine. 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
    KQO Automated Urinalysis System
    JIL Method, Enzymatic, Glucose (Urinary, Non-Quantitative)
    JIO Blood, Occult, Colorimetric, In Urine
    LJX Test, Urine Leukocyte
    JRE Refractometer For Clinical Use
    CDM Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.)
    CEN Dye-Indicator, Ph (Urinary, Non-Quantitative)
    JJB Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.)
    JMT Diazo (Colorimetric), Nitrite (Urinary, Non-Quant)
    JIR Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)
    JIN Nitroprusside, Ketones (Urinary, Non-Quant.)

    GMDN Terms

    Code Name
    57861 Urine analyser IVD, point-of-care

    Identifiers

    Type ID
    Primary 10673486000511

    Customer Contacts

    Phone
    7144631111
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K160372 000

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    4 – 60 Degrees Celsius
    Type
    Handling Environment Humidity
    Temperature Range
    18 – 80 Percent (%) Relative Humidity