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Medical Devices / Submissions and Approvals

PerkinElmer’s EuroImmun Cleared by FDA

June 19, 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.

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