PerkinElmer’s EuroImmun Cleared by FDA

The FDA gave 510(k) clearance to PerkinElmer’s EuroImmun Crithidia luciliae immunofluorescence test (CLIFT) and CLIFT sensitive assays.

CLIFT testing is important in detecting anti-double stranded DNA, one of the markers for the severe rheumatic autoimmune disease known as Lupus.

The EuroImmun’s sensitivity helps reduce false negative results and improve confidence in lupus diagnoses.