Healgen Scientific LLC

Healgen Scientific LLC is a global in-vitro diagnostics (IVD) developer and manufacturer established in 2007 in Houston, Texas. The company specializes in rapid point-of-care (POC) diagnostic testing technologies across multiple therapeutic areas: infectious diseases (COVID-19, influenza, Strep A), toxicology (drug screening, fentanyl/xylazine residue detection), fertility and women's health, oncology, cardiovascular, and metabolic disorders. Healgen's product portfolio includes rapid test cassettes, cups, and oral fluid devices—many FDA 510(k) cleared and CLIA-waived. Notable products include the Accurate® Multi-Drug Urine Drug Screen Cup (18-in-1 detection), Rapid Check® COVID-19/Flu A&B Antigen Test (available for both professional and OTC use), Fentanyl Rapid Tests, Strep A tests, and recently FDA De Novo-cleared Accurate® Oral Fluid Device. The company markets solutions to healthcare providers, workplace testing programs, public health organizations, and consumers. Healgen maintains global service centers and business partnerships across multiple countries and regions. Manufacturing and quality systems support FDA and international regulatory compliance.