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Medical Devices / Submissions and Approvals

FDA Clears GenePOC’s Revogene Instrument and GBS LB Test

June 2, 2017
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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

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