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Medical Devices / Submissions and Approvals

PerkinElmer’s EuroImmun Cleared by FDA

June 19, 2018
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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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