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510(k) Data Aggregation

    K Number
    K232317
    Device Name
    UC-1800 Automatic Urine Analyzer, URIT 11FA Urine Reagent Strips, URIT 12FA Urine Reagent Strips
    Manufacturer
    URIT Medical Electronic Co., Ltd.
    Date Cleared
    2024-04-26

    (267 days)

    Product Code
    JIO, CDM, CEN, JFY, JIL, JIN, JIR, JJB, JMA, JMT, JRE, KQO, LJX
    Regulation Number
    864.6550
    Why did this record match?
    Applicant Name (Manufacturer) :

    URIT Medical Electronic Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The UC-1800 Automatic Urine Analyzer is automated instrument which is intended for professional, in vitro diagnostic use only. Depending on the reagent strips being used, the instruments perform semi-quantitative detection of the following analytes in urine: ascorbic acid, microalbumin, leukocytes, creatinine, ketone, urobilinogen, bilirubin, glucose, protein, specific gravity, blood and pH in urine and for qualitative determination of nitrite in urine hydrometer (optional) can determine the color and turbidity of urine. Test results may provide information regarding the status of carbohydrate metabolism, kidney and liver function, acid-base balance and bacteriuria. The URIT 11FA urine reagent strips provide semi-quantitative tests for ascorbic acid, leukocytes, setone, urobilinogen, bilirubin, glucose, protein, specific gravity, blood and pH in urine and for qualitative determination of nitrite in urine. The URIT 11FA urine reagent strips are for use with the UC-1800 Automatic Urine Analyzer and are for professional, in vitro diagnostic use only. Test results may provide information regarding the status of carbohydrate metabolism, kidney and liver function, acid-base balance and bacteriuria. The URIT 12FA urine reagent strips provide semi-quantitative tests for microalbumin, leukocytes, creatinine, ketone, urobilinogen, bilirubin, glucose, protein, specific gravity, blood and pH in urine and for qualitative determination of nitrite in urine. The URIT 12FA urine reagent strips are for use with the UC-1800 Automatic Urine Analyzer and are for professional, in vitro diagnostic use only. Test results may provide information regarding the status of carbohydrate metabolism, kidney and liver function, acid-base balance and bacteriuria.
    Device Description
    UC-1800 Automatic Urine Analyzer is characterized by fully automated and simple operation. All you need to do is to set test strips and samples, press the START key, and the rest of operations are fully automated with UC-1800, which can measure samples continuously. For each measurement, the instrument automatically performs a series of operation: sample transmitting, sample aspirating, sample dropping, rinsing strip feeding and color identifying, etc. The instrument is used in conjunction with a serial of URIT urine test strips for measuring 15 parameters. Measure results are printed through either built-in printer or external printer. Urine Reagent Strips is used to determine the components to be measured in urine by dry chemistry method together with urine analyzer. Various components to be tested in the urine can result in changes to the colors of corresponding reagent blocks on the Urine Reagent Strips. The depth of reaction color is proportional to the corresponding component to be tested in the urine. Qualitative and semi-quantitative detection can be conducted to the contents of the corresponding detected components. As a reagent for the determination of multiple components in human urine and the most basic test item for clinical urine routine test), it is suitable for the screening test or auxiliary diagnosis for clinical diagnosis, without the specificity for diseases or indications, and urine dry chemistry test is a screening test and cannot be used as a single diagnostic method.
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    K Number
    K082811
    Device Name
    URITEST 10G & 11G URINE REAGENT STRIPS AND URITEST-50 AND URITEST-500B URINE ANALYZERS
    Manufacturer
    URIT MEDICAL ELECTRONIC CO., LTD.
    Date Cleared
    2009-09-11

    (352 days)

    Product Code
    JIO, CDM, CEN, JIL, JIN, JIR, JJB, JMA, JMT, KQO, KSL, LJX
    Regulation Number
    864.6550
    Why did this record match?
    Applicant Name (Manufacturer) :

    URIT MEDICAL ELECTRONIC CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Uritest-50 and Uritest-500B urine analyzers are semi-automated, bench top instruments which are intended for prescription, in vitro diagnostic use only. The instruments perform semi-quantitative detection of the following analytes in urine: leukocytes, ketone, nitrite, urobilinogen, bilirubin, protein, glucose, specific gravity, blood, pH and ascorbic acid. Test results may provide information regarding the status of carbohydrate metabolism, kidney and liver function, acidbase balance and bacteriuria. The instruments use the accompanying check strip for daily calibration. Untest 10G urine reagent strips provide semi-quantitative tests for leukocytes, ketone, nitrite, urobilinogen, bilirubin, protein, glucose, specific gravity, blood and pH in urine. The Uritest 10G urine reagent strips are for use with the Uritest-50 urine analyzer and are for prescription, in vitro diagnostic use only. Test results may provide information regarding the status of carbohydrate metabolism, kidney and liver function, acid-base balance and bacteriuria. Untest 11G urine reagent strips provide semi-quantitative tests for leukocytes, ketone, nitrite, urobilinogen, bilirubin, protein, glucose, specific gravity, blood, pH and ascorbic acid in urine. The Untest 11G urine reagent strips are for use with Untest-500B urine analyzer and are for prescription, in vitro diagnostic use only. Test results may provide information regarding the status of carbohydrate metabolism, kidney and liver function, acid-base balance and bacteriuria.
    Device Description
    The Uritest-50 and Uritest-500B Urine Analyzers are reflectance spectorphotometers that instrumentally measure the reflectance of a reacted Uritest 10G or Uritest 11G urine reagent strip for urinalysis. The Uritest-50 and Uritest-500B Urine Analyzers display and print urinalysis results and can be connected to a laboratory computer for data management.
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