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    K Number
    K042015
    Device Name
    ADVIA CHEMISTRY GLUCOSE OXIDASE ASSAY AND ADVIA CHEMISTRY GLUCOSE HEXOKINASE
    Manufacturer
    BAYER HEALTHCARE, DIAGNOSTICS DIVISION
    Date Cleared
    2004-09-29

    (64 days)

    Product Code
    CGA, CFR
    Regulation Number
    862.1345
    Why did this record match?
    Applicant Name (Manufacturer) :

    BAYER HEALTHCARE, DIAGNOSTICS DIVISION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Bayer ADVIA® 1650 Glucose Hexokinase II assay is an in vitro diagnosic device for use in the quantitative determination of glucose in human cerebrospinal fluid (CSF), serum, plasma (lithium heparin), and urine on the ADVIA® 1650 Chemistry system. Such measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, idiopathic hypoglycemia and insulin overdose. The Bayer ADVIA® 1650 Glucose Oxidase assay is an in vitro diagnostic device for use in the quantitative determination of glucose in human cerebrospinal fluid (CSF), serum, plasma and urine on the ADVIA® 1650 Chemistry system. Such measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, idiopathic hypoglycemia and insulin overdose.
    Device Description
    Not Found
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    K Number
    K033643
    Device Name
    CO2 CALIBRATOR/DILUENT
    Manufacturer
    BAYER HEALTHCARE, DIAGNOSTICS DIVISION
    Date Cleared
    2004-01-08

    (49 days)

    Product Code
    JIT, CO2
    Regulation Number
    862.1150
    Why did this record match?
    Applicant Name (Manufacturer) :

    BAYER HEALTHCARE, DIAGNOSTICS DIVISION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The CO2 Calibrator/Diluent is intended for in vitro diagnostic use to calibrate the enzymatic determination of CO2 on various Bayer diagnostic instruments. To calibrate Technicon RA, opeRA, and ADVIA IMS systems, this product is used in conjunction with Bayer Chemistry Calibrator (Prod. No. T03-1291-62). To calibrate ADVIA Chemistry systems, this product is used as a stand-alone product.
    Device Description
    The CO2 Calibrator/Diluent is an aqueous liquid solution containing bicarbonate at a defined concentration.
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