All SeraCare facilities are ISO 9001 and 13485 certified and comply with cGMP standards.
Our products are completely traceable, from sourcing through processing to delivery—providing a high level of confidence, quality and safety.
Test records—at the donor unit, pooling and finished product stages—are maintained by our quality assurance department in accordance with FDA regulations.
SeraCare’s broad scope of products reduces variability in your process of validation, discovery and production.
Summary Sheet of Our Quality Systems
ISO 9001 Certification
ISO 13485 Certification