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www.fdanews.com/articles/188563-fda-clears-two-oral-fluid-assays-for-premier-biotechs-drug-screener
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FDA Clears Two Oral Fluid Assays for Premier Biotech’s Drug Screener

September 26, 2018

The FDA granted Premier Biotech 510(k) clearance for two additional assays used with its OralTox oral fluid drug screening device.

The Minnesota-based company’s recently cleared assays are used to detect the presence of Oxycodone and Methadone in oral samples.

Premier’s device has been cleared to test for amphetamine, methamphetamine, marijuana, cocaine, opiates, and phencyclidine, in addition to the two new assays.

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