DEUS VULT, LLC

Deus Vult, LLC specializes in in vitro diagnostic (IVD) devices focused on detecting multiple drugs of abuse. Their products include rapid immunoassay test kits and clinical-grade assays for intravenous use, designed for both point-of-care and laboratory settings. These devices are intended to identify controlled substances like opioids and stimulants in biological samples.

Deus Vult, LLC is based in the United States. Their devices are intended for use within the U.S. market, where they must comply with applicable FDA requirements for diagnostic testing, including classification and registration standards.

Deus Vult, LLC’s devices fall under the FDA’s Class II regulatory category. This classification is typically assigned to devices that pose moderate risk and require special controls to ensure their safety and effectiveness, such as validation testing and labeling requirements.

Yes, Deus Vult, LLC’s devices are listed in the FDA’s Unique Device Identification (UDI) database. The UDI system helps track and trace medical devices throughout their distribution and use, ensuring transparency and accountability in the regulatory process.