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510(k) Data Aggregation

    K Number
    DEN240035
    Device Name
    ConcizuTrace™ ELISA
    Manufacturer
    Randox Laboratories Ltd
    Date Cleared
    2025-05-22

    (325 days)

    Product Code
    SES
    Regulation Number
    864.7298
    Why did this record match?
    Applicant Name (Manufacturer) :

    Randox Laboratories Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K230890
    Device Name
    ISE Electrodes
    Manufacturer
    Randox Laboratories Ltd.
    Date Cleared
    2023-09-08

    (161 days)

    Product Code
    CEM, CGZ, JGS
    Regulation Number
    862.1600
    Why did this record match?
    Applicant Name (Manufacturer) :

    Randox Laboratories Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ISE Electrodes on the RX Imola can be used for measurement of the electrolytes sodium, potassium and chloride in serum and urine and for use in diagnosis and treatment of electrolyte imbalance. For in vitro diagnostic use only.
    Device Description
    RX imola is an automated clinical chemistry analyzer complete with dedicated analyzer software. Software functions of the analyzer include the facility to interact with a host computer for direct download of test method selection details for individual samples. A barcode system is used for the rapid identification of patient samples, reagents and QC samples, In addition, the RX imola is fitted with an Ion Selective Electrode (ISE) module that operates in conjunction with specific electrodes for the quantitative in vitro diagnostic determination of Sodium, Potassium and Chloride in serum and urine.
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    K Number
    K182042
    Device Name
    Randox Calcium (Ca)
    Manufacturer
    Randox Laboratories Ltd.
    Date Cleared
    2018-10-23

    (85 days)

    Product Code
    CJY
    Regulation Number
    862.1145
    Why did this record match?
    Applicant Name (Manufacturer) :

    Randox Laboratories Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Randox Calcium (Ca) device is intended for the quantitative in vitro determination in serum, plasma and urine. This product is suitable for use on the RX series analyzer, RX daytona plus. Such measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases and chronic renal failure.
    Device Description
    The Randox Calcium (Ca) kit consists of a ready to use reagent solution.
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    K Number
    K162200
    Device Name
    Randox RX Daytona Plus Magnesium (MG)
    Manufacturer
    RANDOX LABORATORIES LTD
    Date Cleared
    2017-04-28

    (266 days)

    Product Code
    JGJ
    Regulation Number
    862.1495
    Why did this record match?
    Applicant Name (Manufacturer) :

    RANDOX LABORATORIES LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Randox RX daytona plus magnesium (Mg) test system is intended for the quantitative in vitro determination of magnesium concentration in serum, urine and lithium heparinized plasma. Magnesium measurements are used in the diagnosis and treatment of hypomagnesemia (abnormally low levels of magnesium) and hypermagnesemia (abnormally high levels of magnesium).
    Device Description
    The Magnesium kit assay consists of a ready to use reagent solution.
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    K Number
    K152085
    Device Name
    Liquid CO2-2 (LCO2-2)
    Manufacturer
    RANDOX LABORATORIES LTD
    Date Cleared
    2016-02-24

    (212 days)

    Product Code
    KHS
    Regulation Number
    862.1160
    Why did this record match?
    Applicant Name (Manufacturer) :

    RANDOX LABORATORIES LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For the quantitative in vitro determination of Carbon Dioxide in serum and plasma. Carbon Dioxide measurements are used in the diagnosis and treatment of numerous potentially serious disorders associated with changes in body acid-base balance. This in vitro diagnostic device is intended for Rx Only.
    Device Description
    The Liquid CO2-2 (LCO2-2) kit assay consists of ready to use reagent solutions.
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    K Number
    K153435
    Device Name
    Direct HDL Cholesterol (HDL)
    Manufacturer
    Randox Laboratories Ltd
    Date Cleared
    2016-01-08

    (42 days)

    Product Code
    LBS
    Regulation Number
    862.1475
    Why did this record match?
    Applicant Name (Manufacturer) :

    Randox Laboratories Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For the quantitative in vitro determination of HDL Cholesterol in serum and plasma. Such measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis and renal diseases and for the assessment for the risk of developing cardiovascular disease. This in vitro diagnostic device is intended for Rx Only.
    Device Description
    The Direct HDL Cholesterol (HDL) kit assay consists of ready to use reagent solutions. CATALOGUE NUMBER: CH8311 R1. Enzyme Reagent 1 4 x 20 ml R2. Enzyme Reagent 2 4 x 9 ml REAGENT COMPOSITION R1. Enzyme Reagent 1 N,N-Bis(2-hydroxyethyl)- 2-aminoethanesulfonic acid N-(2-hydroxy-3-Sulfopropyl)- 3,5-dimethoxyaniline, sodium salt (HDAOS) Cholesterol Esterase [E.C.3.1.1.13. Microorganism] Cholesterol Oxidase [E.C.1.1.3.6. Streptomyces sp] Catalase [E.C.1.11.1.6. Microbial] Ascorbate oxidase [EC.1.10.3.3. Acremonium sp.] Initial Concentration of Solution 100 mM, pH 6.6 (+25 °C) 0.7 mM ≥800 U/L ≥500 U/L ≥300 KU/L ≥3000 U/L R2. Enzyme Reagent 2 N,N-Bis(2-hydroxyethyl)- 2-aminoethanesulfonic acid 4-Aminoantipyrine Peroxidase [E.C.1.11.1.7, Horse Radish, +25°C] Sodium Azide Surfactants Initial Concentration of Solution 100 mM, pH 7.0 (+25 °C) 4.0 mM ≥3500 U/L 0.05 w/v % 1.4 % w/v %
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