Product portfolio

Molecular Diagnostics Assays

Setting the standard in performance

Our unrivaled investment in research and development allows us to stay ahead of constantly evolving diseases, lets you inform the best possible treatment decisions, and ensures we can keep the blood supply safe for all. Through an unrelenting dedication to innovation, Roche consistently delivers industry leading breakthroughs:

Complementing our range of systems is a broad and expanding portfolio of assays held to rigorous performance standards. We continuously invest in developing new solutions, so you’re equipped to meet challenges today and into the future.
Our assay portfolio spans across a wide range of diseases. Explore our key diagnostic fields below.

Molecular Assay Menu

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Molecular Assay Menu

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*DPX has been submitted to the FDA as a Master File and will not have a regulatory classification; it will not be cleared, licensed or approved by the FDA.

‡For Research Use Only. Not for use in diagnostic procedures.

† This product is in development. This product is not available for use in the U.S.

*This test will be submitted to the FDA as a Master File and will not have a regulatory classification, and will not be cleared, licensed or approved by the FDA.

§This test has not been FDA cleared or approved;

This test has been authorized by FDA under an EUA for use by authorized laboratories;

This test has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens; and

This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of theemergency use of in vitro diagnostic tests for detection and/or diagnosis of COVID-19 under section 564(b)(1) of the Act, 21 U.S.C. §360bbb-3(b)(1), unless the authorization is terminated or revoked sooner

‖This workflow for the test has not been reviewed by the FDA. The test has been validated but FDA’s independent review of thisvalidation is pending. This pooling workflow is distributed in accordance with Section IV.C of the FDA policy for Coronavirus Disease-2019 Tests during the Public Health Emergency (Revised) at https://www.fda.gov/media/135659.

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