Device Trials

400 FDA submissions and counting.

Rigorous testing and analysis by leading experts so you can pave the way to a healthier future.

• Completion of FDA submission protocols per your needs
• Accessible in-house principal investigators with expertise in all clinical and anatomic pathology disciplines
• Abilities to engage non-laboratory professionals for true “point-of-care” evaluations
• Research staff certified in Human Research Subject Protection
• Experienced research technologists and coordinators
• GCP-certified scientists and technologists
• Extended lab hours
• Fast turnaround with study start-up
• Access to large and diverse quantity of predicate methods

A modular clinical chemistry and immunochemistry analyzer beside blood collection tubes.

INSIGHTS

December 11, 2023

New Areas of Discovery and Collaboration

Since its inception, TriCore’s Research Institute has experienced steady and continuous growth, emphasizing research in the field of infectious diseases. During the pandemic, the focus was on COVID Emergency Use Authorizations, which were crucial. The Institute is now diversifying to encompass more intricate studies, such as more complex COVID 510(k) submissions and other respiratory viruses….

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November 13, 2023

TRI Partners with Sponsors for 510(k) Submissions

A 510(k) submission is a premarket submission made to the U.S. Food and Drug Administration (FDA) for the purpose of obtaining clearance to market a medical device or instrument in the United States. An in-vitro diagnostic (IVD) medical device manufacturer may need to submit a 510(k) application if it intends to introduce a new IVD…

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September 13, 2023

TriCore Research Institute: A Reliable Partner in Innovation

In the dynamic landscape of medical research and technological advancements, TriCore Research Institute (TRI) has partnered with organizations to make scientific advances in medicine Infectious Disease Research Studies The year 2020 marked a watershed moment for TriCore Research Institute (TRI). The outbreak of the SARS-CoV-2 pandemic underscored the importance of agility and continuity in research…

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Connect with us to explore how TriCore Research Institute can help you venture into a new frontier with absolute confidence.

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