From 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.
FDA-Registered Facility
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ISO 13485:2016
FDA cGMP Standards
Compliance program
EUA-Aligned Production Processes
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510(k)-Aligned Production Processes
Compliance program
BLA-Aligned Production Processes
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FDA
Quality certification
EUA
Quality certification
BLA
Quality certification
FDA510K
Quality certification
FDAEUA
Quality certification
FDABLA
Quality certification
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
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
KSL Biomedical, IncFounded in 2017, KSL Biomedical develops and manufactures diagnostic tests while providing contract research, clinical, quality, and regulatory services for medical-device and in-vitro diagnostic companies. Based in Buffalo, New York, the company combines its own assay development and New York State manufacturing with integrated clinical laboratories in the United States and Canada. Its team includes specialists who have taken more than 50 assays and medical devices through validation and FDA 510(k) clearance.CHEEKTOWAGA, NY
OraSure Technologies, IncFounded in 1987 as SolarCare in Bethlehem, OraSure Technologies develops and manufactures non-invasive rapid diagnostic tests and biological-sample collection devices. Now headquartered in Bethlehem and publicly traded since 2000, the company is known for point-of-care testing that brings HIV, HCV and other infectious-disease results closer to patients, alongside DNA Genotek sample-management solutions for genomic and microbiome research. Its OraQuick platform includes the first FDA-approved, CLIA-waived rapid HCV test and an oral-fluid HIV self-test.325413BETHLEHEM, PA