- BioFire FilmArray (12 modules)
- Cepheid Gene Xpert (2 x 16 modules)
- Roche Cobas 6800
- Hologic Panther Fusion
- BioRad CFX (2)
- BioRad CFX Opus
- Applied Biosystems QuantStudio Dx
- Applied Biosystems QuantStudio 5 (2)
- Applied Biosystems QuantStudio 7 Flex
- Applied Biosystems 7500
- Applied Biosystems 7500 Fast (2)
- Applied Biosystems 7500 Fast Dx (2)
- Luminex MAGPIX
- Becton Dickenson BD MAX™
- DiaSorin LIAISON® MDX (4)
Clinical Comparator Testing
The work performed in our clinical comparator laboratories supports EUA and 510(k) submission filings through FDA, accelerating product approvals and market access for our customers.
Through the COVID-19 pandemic, work in these laboratories assisted customers in moving diagnostic devices through regulatory approvals. Our expertise and instrumentation support the process at a world-class level.
CAPABILITIES
Our clinical comparator capabilities meet the ever-evolving needs of our customers by hosting the necessary specialized instrumentation. Work performed in our CAP/CLIA regulated laboratories includes testing to support the first FDA-cleared over-the-counter COVID-19 test.
As new disease outbreaks occur, such as the 2023 Mpox outbreak, clients call on MRIGlobal for help in supporting approvals for these diagnostics as well. This necessitates constantly bringing new instrumentation on board to meet these needs.
INSTRUMENTATION
Visit an overview of all of our capabilities between Clinical Comparator Testing and Validation & Verification
Work with us
MRIGlobal looks forward to contributing our expertise where it matters most.
Contact us to learn more about how we can help with your next endeavor.