AQUIOS PLG Panel 8 x 50 Tests

B43610


The AQUIOS PLG Panel is for use on the AQUIOS CL flow cytometer system. The reagent combines two fluorescent-labeled monoclonal antibodies in a single reagent formulation. It is intended “For In Vitro Diagnostic Use” for the identification and enumeration of CD4+ absolute cell count and CD4+ lymphocyte percentage when used in combination with AQUIOS Flow-Count Fluorospheres as a single platform measurement. This reagent is indicated for use in the immunologic assessment of patients having, or suspected of having, immune deficiency.

Specifications

Regulatory Status CE
Format Liquid
Volume 8 x 50 Tests

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.