For 34 years, MOSS Inc. has made liquid-stable immunoassay reagents for the IVD and life-sciences markets, including substrates, conjugates and assay components. Based in Maryland, the company combines custom assay development and conjugation work with bulk manufacturing that can produce 2,000-liter batches and multiple lots weekly. MOSS operates under ISO 9001:2015 guidelines and supplies diagnostic, pharmaceutical, biotechnology and veterinary manufacturers worldwide.
ISO 9001:2015
Meso Scale Diagnostics, LLCRockville-based Meso Scale Diagnostics develops and manufactures immunoassay instruments, assay kits, reagents, and related services for measuring biomarkers in biomedical research and pharmaceutical development. Its S-PLEX platform extends that work to femtogram-per-milliliter sensitivity, enabling researchers to quantify very low-abundance proteins in biological samples. The company’s quality systems have been certified to ISO 9001:2015 and ISO 13485:2016, with the latter covering in-vitro diagnostic product design and development.ROCKVILLE, MD
Vector Laboratories, IncFounded in 1976, Newark-based Vector Laboratories makes research reagents and critical components that help scientists detect, label, visualize, and conjugate biomolecules. The company began in immunohistochemistry and has grown into a life-science manufacturing partner supporting research in areas such as neuroscience, cancer, and infectious disease, with custom capabilities extending from recombinant antibody production to bioconjugate development. Its ISO 9001:2015-certified operations now span the United States, the UK, and Europe.PLAIN CITY, OH
Enzo Life Sciences, IncEstablished in 1976, Enzo Life Sciences develops and manufactures labeling and detection technologies that support life-science research, drug discovery, biopharmaceutical development, and diagnostics. From its Long Island headquarters campus, the company combines in-house U.S. manufacturing with more than 45 years of experience and has produced over 20,000 life-science products. Enzo also provides custom and GMP manufacturing through facilities certified to ISO 9001 and ISO 13485.FARMINGDALE, NY
Maxim Biomedical, IncFrom its Rockville, Maryland facility, Maxim Biomedical develops and manufactures diagnostic tests while helping healthcare companies and government agencies move assays from concept to commercial production. Founded more than 20 years ago, the family-led company produces millions of tests each month in an FDA-registered, ISO 13485:2016-certified operation with capacity exceeding 15 million devices monthly. Its own products include HIV surveillance assays and the ClearDetect COVID-19 Antigen Home Test, alongside contract development and manufacturing for partners worldwide.ROCKVILLE, MD