SCIMEDX specializes in immunofluorescence, ELISA and membrane technologies for a variety of unique and routine autoimmune and infectious diseases.
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.