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510(k) Data Aggregation

    K Number
    K082091
    Device Name
    TRI T-STAT REAGENT ASSAY (DRIED FORM) MODEL 25107-00
    Manufacturer
    Date Cleared
    2009-04-15

    (265 days)

    Product Code
    Regulation Number
    864.5220
    Why did this record match?
    Applicant Name (Manufacturer) :

    REAMETRIX INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Dry Tri T-STAT (CD3/CD4/CD8) reagent, intended for in vitro diagnostic use, is a three color immunofluorescence stain for the labeling, identification, and enumeration of helper/inducer (CD3+CD4+) and cytotoxic/suppressor (CD3+CD8+) T lymphocytes combined with a precise number of fluorescent counting beads to provide absolute CD4+ and CD8+ T-Cell counts on a single platform. This reagent is intended to be used for flow cytometric analysis of erythrocyte-lysed human whole blood. The Tri T-STAT Reagent can be used to monitor forms of immunodeficiency.
    Device Description
    The Dry Tri T-STAT (CD3/CD4/CD8) reagent contains Atto488 - labeled CD4 monoclonal antibody (clone RPA-T4); phycoerythrin(PE) - labeled CD8 monoclonal antibody (clone LT8); and PE = Dyomics649 - labeled CD3 monoclonal antibody (clone UCHT1) formulated with fluorescent counting beads and stabilizers. The conjugated antibodies and beads are dispensed into flow cytometer compatible plastic tubes and dried. The material in each tube is used to process a single sample. The Dry Tri T-STAT (CD3/CD4/CD8) reagent, three color immunofluorescence stain, labels, identifies, and enumerates helper/inducer (CD3+CD4+) and cytotoxic/suppressor (CD3+CD8+) T lymphocytes. Combined with a precise number of fluorescent counting beads, in each tube, the reagent provides absolute CD4+ and CD8+ T-Cell counts on a single platform.
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