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510(k) Data Aggregation

    K Number
    K053031
    Device Name
    EXTENDSURE HBFASC CONTROL
    Manufacturer
    CANTEBURY SCIENTIFIC LTD.
    Date Cleared
    2005-12-07

    (41 days)

    Product Code
    JCM
    Regulation Number
    864.7415
    Why did this record match?
    Applicant Name (Manufacturer) :

    CANTEBURY SCIENTIFIC LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Hemoglobin FASC Variant Control kit contains HbA, HbF, HbS and HbC. The control is intended as a position marker for hemoglobin variant analysis methods such as ion exchange HPLC, capillary electrophoresis, cellulose acetate and agar/agarose gel electrophoresis. The Hemoglobin FASC control will assist in defining the elution time on HPLC or capillary electrophoresis or migration distance on electrophoresis. In this way the common hemoglobin variants can be identified and rare variants that elute close to these can be distinguished for further characterization. The control is for in vitro diagnostic use only and should not be used past the expiry date.
    Device Description
    The Hemoglobin FASC Variant Control kit contains HbA, HbF, HbS and HbC. It contains stabilizers and preservatives to maintain the stability of the hemoglobin variants. The product is provided in a lyophilized form and is reconstituted with 1.0 ml of reconstitution fluid (0.09% sodium azide) prior to use.
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