www.fdanews.com/articles/181999-fda-clears-genepocs-revogene-instrument-and-gbs-lb-test
FDA Clears GenePOC’s Revogene Instrument and GBS LB Test
June 1, 2017
GenePOC has received FDA clearance for its GenePOC GBS LB assay and its Revogene instrument.
The Revogene is an automated, stand-alone instrument for molecular diagnostic testing that can run up to 8 samples at a time.
The GenePOC GBS (Group B Streptococcus) LB assay detects GBS colonization from Lim Broth samples.
The instrument was released on the European market in the first quarter of 2017. — Cynthia Jessup