Since 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.
ISO 13485:2016
FDA Blood Establishment Registration (Massachusetts #1270029)
Registration
FDA Medical Device Establishment Registration (Massachusetts #3007088335, Maryland #3003610890)
Registration
ISO 13485:2016 MDSAP Certification (MDSAP 689354)
EC 1069/2009 and EU 142/2011 Approval (Massachusetts #MA-TEC-0003; Maryland #MD-TEC-0002)
Compliance program
Massachusetts Board of Pharmacy License (Massachusetts #WD463)
Registration
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
LGC Clinical DiagnosticsLGC Clinical Diagnostics manufactures quality measurement tools, biological materials and reagent components that help laboratories and diagnostic developers validate assays and produce reliable results. Part of LGC Group, it brings together five IVD quality-control manufacturers with The Native Antigen Company, whose infectious-disease antigens and antibodies support research into emerging diseases. The business serves more than 20,000 customers in over 100 countries and has more than 35 years of industry experience.EDGEWOOD, NY