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510(k) Data Aggregation
K Number
K023335Device Name
QCS HER2 IMMUNOCONTROLS (PRODUCT NO. C010)
Manufacturer
QC SCIENCES, LLC
Date Cleared
2003-06-18
(254 days)
Product Code
NJW
Regulation Number
864.1860Why 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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