Oral Fluid Drug Screen Device Gains 510(k) Clearance

March 9, 2018

Premier Biotech received a 510(k) clearance for its product OralTox, a rapid oral fluid drug screen device.

The device uses oral fluid as a testing matrix and detects up to 12 drugs simultaneously. Unlike for urine testing, the collection can be fully observed without privacy concerns and it is resistant to alteration.

The test can detect amphetamine, cocaine, marijuana, methamphetamine, opiates and phencyclidine (PCP), and the test can be sent to a laboratory for confirmation. It also offers confirmations of presumptive positive results.

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