Diagnology
This article was originally published in The Gray Sheet
Executive Summary
Ireland-based company files 510(k) with FDA for the Pockit HSV 2 rapid test, a point-of-care test for herpes simplex virus type 2. If cleared by FDA, the test would be the first that would allow physicians to identify HSV-2 at the point of care. Results are available in about 10 minutes, Diagnology states. The company, which has a U.S. unit in Walpole, Massachusetts, launched the test in Europe a year ago. The test is an immuno-based assay and can be used in physician offices with whole blood or serum in the lab
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