AMERICAN SCREENING, L.L.C.

American Screening, LLC specializes in in vitro diagnostic (IVD) devices focused on detecting multiple drugs of abuse. Their portfolio includes rapid immunoassay test kits (such as OneScreen and Discover) for point-of-care use, as well as clinical-grade systems (like Precision DX and Discover Plus) designed for laboratory testing. These devices are intended for identifying substances like opioids, cocaine, and benzodiazepines in biological samples such as urine or oral fluid.

American Screening, LLC is based in the United States. Its devices are developed in compliance with FDA requirements for in vitro diagnostics, including regulatory classifications and traceability standards. Since these products are classified under FDA’s Class II and Unclassified (U) categories, they must meet specific performance and safety criteria for drug-of-abuse testing in regulated medical settings.

Yes, American Screening, LLC’s devices are included in the FDA’s Unique Device Identifier (UDI) database. This registry ensures traceability and transparency for Class II and Unclassified (U) diagnostic tests, particularly those used for detecting drugs of abuse in clinical or point-of-care environments. Listing in the UDI database is a requirement for FDA-compliant IVD devices.

American Screening, LLC’s devices fall under the FDA’s Class II and Unclassified (U) regulatory classifications. Class II devices typically require special controls to ensure their safety and effectiveness, while Unclassified (U) devices may involve lower-risk diagnostic tests that still require compliance with FDA guidelines. These classifications apply because the devices are intended for detecting drugs of abuse in controlled medical settings, where accuracy and reliability are critical.