For 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.
ISO 13485:2016 Certification
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cGMP Compliance
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FDA Blood Establishment Registration, Massachusetts #1270029
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FDA Medical Device Establishment Registration, Massachusetts #3007088335
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FDA Medical Device Establishment Registration, Maryland #3003610890
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MDSAP Certification, MDSAP 689354
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EC 1069/2009 and EU 142/2011 Approval
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Massachusetts Board of Pharmacy License, Massachusetts #WD463
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