Born from Douglas A. Granger’s Penn State lab, Salimetrics has made salivary bioscience tools and testing services since 1998, helping researchers turn saliva and dried blood spots into reliable biomarker data. Its work spans validated assay kits, participant collection systems and CoreLab+ analysis, with methods used in more than 10,000 studies. The company also operates FDA-registered, ISO 13485:2016-certified facilities and a CLIA-certified laboratory for research and diagnostic applications.
FDA Registered
Registration
ISO 13485:2016 Certified
21 CFR 820 (cGMP) Compliant
Compliance program
CLIA Certified Laboratory
CE Marked Diagnostic Products
FDA
Quality certification
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
SeraCareSince the early 1980s, SeraCare has supported the diagnostic testing industry with biological materials that help laboratories and assay developers establish confidence in their results. The Milford-based company is known for patient-like reference materials used in emerging clinical genomics applications, while its ISO 13485-certified, cGMP-compliant facilities provide traceability from sourcing through delivery.IJAMSVILLE, MD
Fertility Solutions IncSince Susan Rothmann founded it in Cleveland in 1992, Fertility Solutions has built its identity around specialized semen-analysis expertise. Now owned by Anna-Marie Bort, who joined the company in 2000 and purchased it in 2020, the firm serves laboratories and clinical researchers with human sperm-based quality controls and related support for consistent testing.CLEVELAND, OH
SeraCareFor more than 30 years, SeraCare has made biological reference materials, quality controls, diagnostic components, and reagents that help assay developers and clinical laboratories develop and verify diagnostic tests. Its Seraseq platform extends that work into highly multiplexed, patient-like materials for next-generation sequencing, including custom standards tailored to specific genomic variants and workflows. SeraCare’s facilities are ISO 13485-certified, cGMP-compliant, and maintain traceability from sourcing through delivery.GAITHERSBURG, MD