About us SCIMEDX Corporation is a highly flexible company, with over 30 years in the medical diagnostics industry, specializing in IFA, ELISA, and automated laboratory platforms, with a focus on autoimmune diseases. The strength of the organization is the collective diversified experiences of the personnel in many areas of diagnostics and biochemistry. Our long time experience with the FDA regulations as a manufacturer of medical diagnostic kits provides a practical approach to domestic as well as international regulatory compliance. SCIMEDX has produced Tissue substrates slides, HEp2, FTA, Legionella, and DNA antigens for autoimmune IFA kits for over twenty-five years. Our ELISA kits utilize competitive binding and traditional sandwich techniques for unique autoimmune disease markers. Our company also develops unique assays that allow for a continuous flow of new and innovative technologies. We believe that quality belongs to everyone. Our quality system consists of integrated processes requiring planning, commitment, actions and follow up. We are harmonized with ISO 13485:2003, CMDR and compliant with the requirements with European medical device directives (Medical Device Directive 93/42/EEC, and In Vitro Diagnostic Medical Device Directive 98/79/EEC) in order to CE Mark our products.