
PRODUCT PROCEDURE NOTE: For complete instructions, limitations and warnings, please refer to the reference guide and package insert before using this screening device. The Alere Oratect® Oral Fluid Drug Screen Device is a one-step lateral flow immunoassay device. The test is a prescription assay. This product is for in vitro diagnostic use and it can be used at the Point-of-Care site. The Alere Oratect® Oral Fluid Drug Screen Device provides only preliminary drug test results. For a quantitative result or for a confirmation of a presumptive positive result obtained by the Alere Oratect® Oral Fluid Drug Screen Device, a more specific alternative method must be used. GC/MS or LC/MS/MS is the preferred confirmatory method. The samples for confirmatory testing should be collected with the oral fluid confirmation tube provided.
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