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510(k) Data Aggregation

    K Number
    K023335
    Device Name
    QCS HER2 IMMUNOCONTROLS (PRODUCT NO. C010)
    Manufacturer
    QC SCIENCES, LLC
    Date Cleared
    2003-06-18

    (254 days)

    Product Code
    NJW
    Regulation Number
    864.1860
    Why did this record match?
    Applicant Name (Manufacturer) :

    QC SCIENCES, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For in Vitro Diagnostic Use: QCS HER2 ImmunoControls, are intended for a laboratory to control semi-quantitative immunohistochemistry using different HER2/neu antibodies. Each QCS HER2 control slide contains four control sections prepared from breast cancer ccll lines that represent different levels of Her-2/neu protein expression. The cells are formalin-fixed and paraffin-embedded. These controls ensure that performance of immunohistochemical staining is consistent in one laboratory over time and also aids in correlation with the results of other laboratories.
    Device Description
    QCS HER2 ImmunoControls: This product provides appropriate control for semi-quantitative immunohistochemistry using polyclonal or monoclonal HER2/neu antibodies. Each slide contains four control sections prepared from breast cancer cell lines that represent different levels of Her-2/neu protein expression (-, 1+, 2+, 3+). These cells are formalin-fixed and paraffin-embedded, the slide is positively charged.
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