tetraCHROME CD45-FITC/CD4-PE/CD8-ECD/CD3-PC5 Antibody Cocktail, 50 Tests, CE, IVD
CYTO-STAT tetraCHROME CD45-FITC/CD4-RD1/ CD8-ECD/CD3-PC5 and CYTO-STAT tetraCHROME CD45-FITC/CD56-RD1/CD19-ECD/CD3-PC5 Monoclonal Antibody Reagents are for use on the Cytomics FC 500, Navios, and Navios EX Flow Cytometers. The reagents are also used with the tetraCXP System for FC 500 Flow Cytometry System, Navios tetra Software for the Navios System, and Navios EX tetra Software for the Navios EX System.
Used alone or in combination with the automated systems, the reagents are intended "For In Vitro Diagnostic Use" and allow simultaneous identification and enumeration of total CD3+, total CD4+, total CD8+, dual CD3+CD4+, dual CD3+CD8+ and/or total CD3+, CD19+ and CD3-CD56+ lymphocyte percentages and absolute counts in whole blood by flow cytometry. The systems also provide the CD4/CD8 ratio when using CD45-FITC/CD4-RD1/ CD8-ECD/CD3-PC5. These reagents are indicated for use in the immunologic assessment of patients having or suspected of having immune deficiency.
|Specificity||CD45, CD4, CD8, CD3|
|Fluorochrome||FITC, RD1, ECD, PC5|
|Regulatory Status||IVD, CE|
|Flow Product Line||cyto-stat|
NOT ALL PRODUCTS ARE AVAILABLE IN ALL COUNTRIES
PRODUCT AVAILABILITY AND REGULATORY STATUS DEPENDS ON COUNTRY REGISTRATION PER APPLICABLE REGULATIONS
The listed regulatory status for products correspond to one of the below:
IVD: In Vitro Diagnostic Products. These products are labeled "For In Vitro Diagnostic Use."
ASR: Analyte Specific Reagents. These reagents are labeled "Analyte Specific Reagents. Analytical and performance characteristics are not established."
CE: Products intended for in vitro diagnostic use and conforming to European Directive (98/79/EC). (Note: Devices may be CE marked to other directives than (98/79/EC)
RUO: Research Use Only. These products are labeled "For Research Use Only. Not for use in diagnostic procedures."
LUO: Laboratory Use Only. These products are labeled "For Laboratory Use Only."
No Regulatory Status: Non-Medical Device or non-regulated articles. Not for use in diagnostic or therapeutic procedures.