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510(k) Data Aggregation

    K Number
    K181024
    Device Name
    DUS 2GP Reagent Strips, DUS 5 Reagent Strips, DUS 10 Reagent Strips
    Manufacturer
    DFI Co., Ltd.
    Date Cleared
    2018-05-23

    (35 days)

    Product Code
    JIL, CDM, CEN, JIN, JIO, JIR, JJB, JMT, JRE, LJX
    Regulation Number
    862.1340
    Why did this record match?
    Applicant Name (Manufacturer) :

    DFI Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This device is intended for the in vitro measurement of the following in urine: Leukocyte, Nitrite, Urobilinogen, Protein, pH, Blood, Specific gravity, Ketone, Bilirubin, Glucose. These strips are intended for prescription, in vitro diagnostic use only and they are visually read. DUS 2GP reagent strips provide qualitative and semiquantitative measurements for protein, and glucose in urine specimens. Test results may provide information regarding the status of carbohydrate metabolism and kidney function. DUS 5 reagent strips provide qualitative and semiquantitative measurements for leukocytes, nitrite, blood , protein, and glucose in urine specimens. These measurements are used to aid in the diagnosis of metabolic disorders, kidney function anomalies and urinary tract infections. DUS 10 reagent strips provide qualitative and semiquantitative measurements for specific gravity, pH, leukocytes, nitrite, protein, glucose, ketone, urobilinogen, bilirubin and blood in urine speciments are used to aid in the diagnosis of metabolic disorders, kidney function anomalies, urinary tract infections and liver function.
    Device Description
    The DUS Series are urine test strips with different reagent pads for the determination of specific gravity, pH, leukocytes, nitrite, protein, glucose, ketone, urobilinogen, bilirubin and blood affixed onto plastic strips. of which leukocyte, nitrite, urobilinogen, protein, pH, blood, specific gravity, ketone, bilirubin and glucose reagent pads are affixed onto the plastic strips. The reagent pads react with analytes in the urine giving a visible color. Results are confirmed by comparison of the test strip with the color chart on the container. For each color result for each analyte, a semiquantitative value is available on the box label (e.g. bilirubin results include negative, 1, 2, and 4 mg/dL) and the associated qualitative result (e.g. bilirubin results include negative. +. ++, +++).
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    K Number
    K171521
    Device Name
    DUS R-50S (Urine Chemistry system)
    Manufacturer
    DFI Co., Ltd.
    Date Cleared
    2018-02-16

    (268 days)

    Product Code
    JIL, CDM, JFY, JIN, JIO, JIR, JJB, JMT, JRE, KQO, LJX
    Regulation Number
    862.1340
    Why did this record match?
    Applicant Name (Manufacturer) :

    DFI Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The DUS R-50S System provides a qualitative measurements for specific gravity, pH, leukocytes, nitrite, protein, glucose, ketone, urobilinogen, bilirubin, blood, microalbumin and creatinine in urine specimens. These measurements are used to aid in the diagnosis of metabolic disorders, kidney function anomalies, urinary tract infections and liver function. The system is intended for prescription, in vitro diagnostic use only.
    Device Description
    The DUS R-50S (Urine Chemistry system) is a portable analyzer. It is designed to read only DUS Series for urinalysis. This analyzer reports semi-quantitatively assays for 12 urine analytes [Leukocyte, Nitrite, Urobilinogen, Protein, pH, Blood, Specific gravity, Ketone, Bilirubin, Glucose, Microalbumin, Creatinine]. Reagent strip results are automatically displayed on the screen. The DUS R-50S is intended for in vitro diagnostic use only
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    K Number
    K102188
    Device Name
    CYBOW READER, MODELS 300 & 720
    Manufacturer
    DFI CO., LTD.
    Date Cleared
    2011-08-09

    (371 days)

    Product Code
    KQO, CDM, CEN, JIL, JIN, JIO, JIR, JJB, JMA, JMT, JRE, LJX
    Regulation Number
    862.2900
    Why did this record match?
    Applicant Name (Manufacturer) :

    DFI CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The CYBOW Reader 300 and CYBOW Reader 720 urine chemistry analyzers are semi-automated analyzers intended to be used with CYBOW 11 and CYBOW 10 Reagent Strips as a test system to semi-quanititatively or qualitatively measure the specified analytes in urine as follows: glucose, urobilinogen, pH, ketone, occult blood, protein, bilirubin, ascorbic acid, nitrite, leukocyte, and specific gravity. These measurements are useful in the evaluation of renal, urinary and metabolic disorders. The CYBOW Reader 300 and CYBOW Reader 720 urine chemistry test systems are intended for prescription and in vitro diagnostic use only.
    Device Description
    CYBOW Reader 300, 720 are reflectance photometer. The strip is illuminated by white light, and there flected light from the strip is detected by a color Image Sensor. The RGB signals are digitized, and this digitized image is evaluated by the processor. The intelligent image analyzer SW locates the strip and the pads, and based on these color data the parameter values are determined. The results with the date and time of the measurement as well as the sequence number and the ID are stored and printed out by the internal printer.
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