SCIMEDX

The strength of the organization is the collective diversified experiences of the personnel in many areas of diagnostics and biochemistry. The 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. The ELISA kits utilize competitive binding and traditional sandwich techniques for unique autoimmune disease markers. SCIMEDX also develops unique assays that allow for a continuous flow of new and innovative technologies.

The product range consists out of 6 product categories:

• IFA Autoimmune Assays
• IFA Bacterial Assays
• IFA Parasitic Assays
• IFA Viral Assays
• ELISA Assays
• Rapid Assays

SCIMEDX believes that quality belongs to everyone. The quality system consists of integrated processes requiring planning, commitment, actions and follow up. SCIMEDX is 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 the products.

Contact Sanbio for more information about the SCIMEDX product portfolio and BeNeLux deliveries.