www.fdanews.com/articles/187274-perkinelmers-euroimmun-cleared-by-fda
PerkinElmer’s EuroImmun Cleared by FDA
June 18, 2018
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.