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    K Number
    K972812
    Device Name
    RAICHEM PREALBUMIN SPIA
    Manufacturer
    HEMAGEN DIAGNOSTICS, INC.
    Date Cleared
    1997-08-28

    (31 days)

    Product Code
    DDS
    Regulation Number
    866.5060
    Why did this record match?
    Product Code :

    DDS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Prealbumin SPIA™ is a quantitative turbidimetric assay intended for the detection of prealbumin levels in human serum and plasma. Measurement of prealbumin levels may aid in the assessment of an individual's nutritional status.
    Device Description
    Raichem's Prealbumin SPIA ™ is a quantitative turbidimetric assay for the detection and measurement of prealbumin in human serum and plasma. The assay has been standardized to a CAP Reference Preparation. The assay reagents consist of a polymer diluent, a polyclonal antibody to human prealbumin, calibrators, and controls. In this assay, a complex forms between the prealbumin, and anti-prealbumin antibodies causing turbidity. The change in optical density is proportional to the amount of prealbumin present. A quantitative determination of the amount of prealbumin present in a serum/plasma sample is made by comparison to a standard curve.
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    K Number
    K964781
    Device Name
    IMMAGE IMMUNOCHEMISTRY SYSTEM PREALBUMIN (PAB) REAGENT
    Manufacturer
    BECKMAN INSTRUMENTS, INC.
    Date Cleared
    1997-05-09

    (163 days)

    Product Code
    DDS
    Regulation Number
    866.5060
    Why did this record match?
    Product Code :

    DDS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The IMMAGE Immunochemistry System Prealbumin (PAB) reagent, in conjunction with Beckman Calibrator 3, is intended for use in the quantitative determination of human prealbumin concentrations in human serum samples by rate nephelometry. This assay is designed for use with the Beckman IMMAGE Immunochemistry System.
    Device Description
    The IMMAGE Immunochemistry System Prealbumin (PAB) Reagent, in coniunction with Beckman Calibrator 3, is intended for use in the quantitative determination of human prealbumin concentrations in human serum samples. The reagent kit contains one cartridge of reagent, evaporation caps and a lot specific bar code card. Calibrators and control materials are purchased separately.
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