Our Commitment to Quality

Tetracore is committed to supplying high-quality animal and human health diagnostic products, diagnostic reagents, and assays for infectious diseases and BW threat agents and providing laboratory services that are suitable for their intended purpose. The management of Tetracore, who are committed to a continuous quality improvement philosophy, commits to meet or exceed our customers’ needs and expectations, maintain an effective quality management system, and meet regulatory requirements for the products and services we provide.

Quality System

The Tetracore Quality System is structured to ensure compliance with the FDA Quality System Regulations (QSRs), 21 Code of Federal Regulations (CFR) Part 820. All members of Tetracore staff are responsible for the quality of their work and are committed to working within the Quality System. Applicable Tetracore products comply with cGMP regulations. Every process is documented, and records are maintained according to these regulations. Our animal health diagnostic products are compliant with USDA Regulations (Code of Federal Regulation Title 9).

We ensure our customers continued satisfaction by encouraging employee empowerment, development, and fostering an environment of continuous improvement and innovation. Our dedication to customer satisfaction translates to providing a high level of confidence in the quality of our products and services.

Registration and Certification Information

FDA Certified – Registration # 3003517954
USDA Veterinary Biologics Establishment License #644
BSL3 registered with CDC and DOJ to possess and work with select agents.
CDC FSAP (Federal Select Agent Program) Registration #: 20200709-161731
Office for Human Research Protections U.S. Department of Health and Human Services IRB00013052 Tetracore, Inc IRB #1
Federal wide Assurance (FWA) number assigned by the Office for Human Research Protections (OHRP) for Tetracore, Inc, is FWA00031080

Anthrax BioThreat Alert® Kit

Additional information