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510(k) Data Aggregation
K Number
K082091Device Name
TRI T-STAT REAGENT ASSAY (DRIED FORM) MODEL 25107-00
Manufacturer
Date Cleared
2009-04-15
(265 days)
Product Code
Regulation Number
864.5220Why 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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