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
certification
FDA Blood Establishment Registration (Massachusetts #1270029)
registration
FDA Medical Device Establishment Registration (Massachusetts #3007088335, Maryland #3003610890)
registration
ISO 13485:2016 MDSAP Certification (MDSAP 689354)
certification
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