FDA Registered
Manufactured in an FDA registered medical device establishment.
View FDA registrationManufactured in an FDA registered medical device establishment.
View FDA registrationQuality management system certified for medical device manufacturing.
View ISO 13485 certificateLicensed by the California Department of Public Health for IVD manufacturing.
View manufacturing licenseDesigning, manufacturing and supporting immunodiagnostic products worldwide since 1977.
Scientific Leadership
Monobind employs a knowledgeable staff of renowned scientists, quality control professionals, production experts and supporting administrators dedicated to the development and manufacture of high-quality diagnostic products.
Dr. Frederick R. Jerome, Ph.D., President, Founder and Chief Scientific Officer, is an internationally recognized expert in immunoassay development and continues to oversee the scientific direction of Monobind's product portfolio.
With more than 45 successful years in biotechnology, Monobind's team understands the importance of efficiency, cross-functional training, continuous improvement and advanced manufacturing systems that connect quality, production, inventory and operations throughout the company.