QUALIGEN, INC.

Qualigen, Inc. manufactures the FastPack® immunoassay analyzer platform, a point-of-care and laboratory diagnostic system designed for rapid, accurate immunoassay testing in hospitals, clinics, and doctor's offices. The FastPack technology platform specializes in quantitative human chorionic gonadotropin (hCG) testing for women's health diagnostics, with expanding applications in immunoassay testing. The company positions its solutions as quick, simple, and accurate alternatives to traditional laboratory workflows, emphasizing time savings, cost reduction, and improved patient outcomes. Qualigen distributes its analyzers and consumable test kits through group purchasing organization (GPO) partnerships, including recent expansion via Afaxys GPO agreements. The company provides comprehensive customer support including technical assistance, supply ordering, training resources, and safety documentation (SDS). While specific regulatory certifications are not detailed on the primary website content provided, the company operates in the clinical diagnostics space serving hospital and clinic laboratory settings. Manufacturing and service capabilities appear centralized at the Carlsbad, California headquarters location.