Reference Lab Serving Clinical Studies
TSL provides advanced analytic studies specifically tailored for the in vitro diagnostic device (IVD) industry. We specialize in FDA 510(k) and In Vitro Diagnostic Regulation (IVDR) submissions for both the United States and the European Union, offering a comprehensive range of services to meet regulatory and developmental needs.
The Analytic Laboratory of Texas Scientific features state-of-the-art facilities, including a BSL-2 laboratory equipped to handle live viruses, bacteria, and fungi, such as COVID-19, influenza A and B, and respiratory syncytial virus (RSV). Our experienced scientists and analysts are proficient in conducting a wide array of studies, from assay validation to performance evaluation, ensuring that your IVD device meets the highest standards of safety, efficacy, and regulatory compliance.
In addition to standard analytical studies, we offer specialized Temperature and Humidity Related Studies conducted within our temperature and humidity-controlled glovebox. With precise control capabilities, our glovebox can simulate various environmental conditions, including:
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5°C at 85-95% relative humidity (RH)
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5°C at 5% RH
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45°C at 85-95% RH
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45°C at 5% RH
These controlled environments allow for thorough testing of IVD devices under different temperature and humidity conditions, providing valuable insights into device performance and stability.
Whether navigating the regulatory pathways for FDA or EU IVDR approvals or aiming to optimize your product's performance, the analytical laboratory at Texas Scientific is here to support you every step of the way. Contact us to learn how our expertise can help advance your IVD device to success in the global market.