Rockville-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.
ISO 9001:2015 Certification
certification
ISO 13485:2016 Certification
certification
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
Tetracore, IncFor more than 20 years, Rockville-based Tetracore, Inc. has developed diagnostic reagents, assays, and instruments that detect infectious diseases and biothreat agents. Its work spans human and animal health, domestic preparedness, and forensic biology, including the T-COR 8 portable PCR thermocycler and the BioThreat Alert testing platform. Tetracore’s quality system is certified to ISO 13485 and ISO 9001, with laboratories accredited to ISO/IEC 17025.ROCKVILLE, MD
Rockland Immunochemicals, IncEstablished in 1962, Rockland Immunochemicals, Inc. is a privately held biotechnology company with a long history of helping life science researchers develop dependable antibody-based tools. The company operates a 60,000-square-foot manufacturing facility near Philadelphia and serves academic, diagnostic, and biopharma research programs worldwide.325414POTTSTOWN, PA
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