No image
AESKUSLIDES nDNA (Crithidia luciliae)
AESKUSLIDES® nDNA (Crithidia luciliae) is an indirect immunofluorescence assay utilizing Crithidia luciliae coated slides as a substrate for the qualitative and/or semi-quantitative determination of antibodies to native double stranded DNA (dsDNA) in human serum. This in vitro diagnostic assay is used as an aid for the diagnosis of Systemic Lupus Erythematosus (SLE) in conjunction with other clinical and laboratory findings. The assay can be processed manually and analyzed at the microscope or processed and analyzed with HELIOS® Automated IFA System. All suggested results obtained with the HELIOS® Automated IFA System must be confirmed by trained personnel.
Details
Device typeNative DNA antibody (anti-nDNA) IVD, kit, fluorescent immunoassay: A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of antibodies to native DNA (anti-nDNA) in a clinical specimen, using a fluorescent immunoassay method.
FDA categoryAnti-Dna Antibody, Antigen And Control
Device ID04250289510394
AvailabilityPrescription
Single useYes
MRI safetyLabeling does not contain MRI Safety Information