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Instrument & Software: The HELIOS® AUTOMATED IFA SYSTEM is an automated system for immunofluorescence processing with an integrated fluorescence microscope and software for routine laboratory use by professional users under controlled environmental conditions. All suggested results obtained with the HELIOS® AUTOMATED IFA SYSTEM must be confirmed by trained personnel. Assay: AESKUSLIDES® ANA HEp-2-Gamma is an indirect fluorescent antibody assay utilizing HEp-2 cell coated slides as a substrate for the qualitative and/or semi-quantitative determination of antibodies (ANA) in human serum by manual microscopy or with HELIOS® AUTOMATED IFA SYSTEM. This in vitro diagnostic assay is used as an aid in the diagnosis of systemic rheumatic diseases in conjunction with other clinical and laboratory findings. All suggested results obtained with the HELIOS® AUTOMATED IFA SYSTEM instrument must be confirmed by trained personnel.

The HELIOS® AUTOMATED IFA SYSTEM is an automated system for immunofluorescence processing with an integrated fluorescence microscope and software for routine laboratory use by professional users under controlled environmental conditions.