This article was originally published in The Gray Sheet
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
You may also be interested in...
Under EU rules, once a medicinal product has been placed on the market in a country of the EEA – the EU plus Iceland, Liechtenstein and Norway
Trademarks are registered and published for opposition with the US Patent and Trademark Office and are published weekly in the agency's Official Gazette.
The national regulator is to undergo a review in 2021 as the UK begins life as a former EU member, presenting opportunities to be seized.