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510(k) Data Aggregation

    K Number
    K030775
    Device Name
    AUTO I.D. JO-1, SCL-70 & PCNA POSITIVE CONTROL SERUM
    Manufacturer
    IMMUNO CONCEPTS, N.A., LTD
    Date Cleared
    2003-05-12

    (62 days)

    Product Code
    LKJ
    Regulation Number
    866.5100
    Why did this record match?
    Applicant Name (Manufacturer) :

    IMMUNO CONCEPTS, N.A., LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    These are qualitative calibrators/controls to confirm the presence of antibodies to autoantigens (Jo-1, Scl-70, or PCNA) in human serum. Antibodies to Jo-1 are found in patients with polymyositis and dermatomyositis, antibodies to Scl-70 are found in patients with scleroderma, and antibodies to PCNA are found in patients with systemic lupus erythematosus. These optional controls are intended for use with the Immuno Concepts AUTO-ID® Autoantibody Test System.
    Device Description
    AUTO-I.D.® Jo-1 Positive Control Serum (Catalog number 6004) AUTO-I.D.® Sc1-70 Positive Control Serum (Catalog number 6005) AUTO-I.D.® PCNA Positive Control Serum (Catalog number 6006)
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