Through innovative research, science, and technology, we bring you the most important detection tools for clinical, animal health, and domestic preparedness testing.
Providing Advanced Molecular and Immunological Detection
Tetracore is a biotechnology research and development organization that creates innovative kits, assays, reagents, and instruments for the detection of infectious diseases, biological warfare (BW) threat agents, and biological markers. Our solutions have been used by various laboratorians, veterinarians, first responders, and clinicians. In addition, we have strong relationships with various government agencies and related industry partners.
Tetracore offers a broad range of highly-specific, rapid, antibody-based test kits and antibody reagents to detect BW infectious agents and toxins, including the first FDA-cleared test kit for the identification of B. anthracis from colonies.
Tetracore also offers a product line of real-time probe hydrolysis Polymerase Chain Reaction (PCR) reagents and kits for animal pathogens.
In early 2020, Tetracore developed and commercialized a real-time PCR test and serology multiplex test for SARS-CoV-2. Emergency Use Authorization (EUA) applications for both tests have been submitted to the FDA. Both tests are being distributed in accordance with the guidance on Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency, Section IV.D.
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.
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