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510(k) Data Aggregation
K Number
K022528Device Name
IQ PRODUCTS TRIPLE-COLOR FLOW CYTOMETRY REAGENTS, IQ PRODUCTS CD45-FITC/CD4-PE/CD3-CYQ, IQ PRODUCTS CD45-FITC/CD8-PE/CDQ
Manufacturer
Date Cleared
2002-09-11
(42 days)
Product Code
Regulation Number
864.5220Why did this record match?
Applicant Name (Manufacturer) :
IQ CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
IQ Prep Reagent CD45 FITC/ CD19 R-PE/ CD3 CyQ is a triple-color murine monoclonal antibody reagent used to identify and enumerate the percentages of total CD19+ and total CD3+ Iymphoctyes in whole blood by flow cytometry. To monitor for any non-specific staining, the isotypic control IQ Prep Reagent CD45 FITC/ IgG1 R-PE/IgG1 CyQ may be used.
IQ Prep Reagent CD45 FITC/ CD8 R-PE/ CD3 CyQ is a triple-color murine monoclonal antibody reagent used to identify and enumerate the percentages of total CD8+, and dual CD3+/CD8+ lymphoctyes in whole blood by flow cytometry. To monitor for any non-specific staining, the isotypic control IQ Prep Reagent CD45 FITC/ IgG1 R-PE/ IgG1 CyQ may be used.
IQ Prep Reagent CD45 FITC/ CD4 R-PE/ CD3 CyQ is a triple-color murine monoclonal antibody reagent used to identify and enumerate the percentages of total CD3 positive, total CD4 positive, and dual CD3 positive lymphoctyes in whole blood by flow cytometry. To monitor for any non-specific staining, the isotypic control IQ Prep Reagent CD45 FITC/ IgG1 R-PE/ IgG1 CyQ is used.
IQ Prep Reagent CD45 FITC/IgG1 R-PE/IgG1 CyQ is a triple-color murine monoclonal antibody reagent used to monitor the level of nonspecific antibody binding in cell surface staining procedures that use the other IQ Prep Reagents are comprised of the monoclonal antibody to CD45, that is labeled with the fluorochrome FITC, and two other IgG1 subclass monoclonal antibodies that are conjugated to either PE or CyQ fluorochromes.
Device Description
IQ Prep Reagent CD45 FITC/ CD19 R-PE/ CD3 CyQ is a triple-color murine monoclonal antibody reagent used to identify and enumerate the percentages of total CD19+ and total CD3+ Iymphoctyes in whole blood by flow cytometry. To monitor for any non-specific staining, the isotypic control IQ Prep Reagent CD45 FITC/ IgG1 R-PE/IgG1 CyQ may be used.
IQ Prep Reagent CD45 FITC/ CD8 R-PE/ CD3 CyQ is a triple-color murine monoclonal antibody reagent used to identify and enumerate the percentages of total CD8+, and dual CD3+/CD8+ lymphoctyes in whole blood by flow cytometry. To monitor for any non-specific staining, the isotypic control IQ Prep Reagent CD45 FITC/ IgG1 R-PE/ IgG1 CyQ may be used.
IQ Prep Reagent CD45 FITC/ CD4 R-PE/ CD3 CyQ is a triple-color murine monoclonal antibody reagent used to identify and enumerate the percentages of total CD3 positive, total CD4 positive, and dual CD3 positive lymphoctyes in whole blood by flow cytometry. To monitor for any non-specific staining, the isotypic control IQ Prep Reagent CD45 FITC/ IgG1 R-PE/ IgG1 CyQ is used.
IQ Prep Reagent CD45 FITC/IgG1 R-PE/IgG1 CyQ is a triple-color murine monoclonal antibody reagent used to monitor the level of nonspecific antibody binding in cell surface staining procedures that use the other IQ Prep Reagents are comprised of the monoclonal antibody to CD45, that is labeled with the fluorochrome FITC, and two other IgG1 subclass monoclonal antibodies that are conjugated to either PE or CyQ fluorochromes.
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