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Medical Devices / Submissions and Approvals

Techlab Wins FDA Clearance for E. Histolytica Quik Chek Device

June 14, 2017
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Techlab received FDA clearance for E. Histolytica Quik Chek test, a rapid assay for the qualitative detection of E. histolytica in fecal samples. 

The assay specifically detects pathogenic E. histolytica and does not cross-react with non-pathogenic Entamoeba dispar. It targets an adhesin protein unique to E. histolytica.

The test can be used for quick and reliable diagnosis of amebiasis. — Cynthia Jessup

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