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Roche Molecular Diagnostics

http://molecular.roche.com/

Latest From Roche Molecular Diagnostics

FDA: Roche Test Flaws Could Misdiagnose Patients With COVID-19, Flu

The US agency has contacted health care providers to warn them about faulty COBAS SARS-CoV-2 and Influenza A/B Nucleic Acid Tests for use on the COBAS Liat System.

Regulation Commercial

FDA To Lower Scrutiny Of CMV Tests Used In Transplant Patients

A proposed rule from the US agency would move the in vitro diagnostics from high-risk class III to class II with special controls, eliminating the requirement for a PMA.

Regulation Review Pathway

COVID-19 Registry Aims To Map And Address Potential Test Shortages

Medtech industry group AdvaMed has developed a registry to share data on how many COVID-19 diagnostic tests are available and where they are, with a goal of foreseeing and nipping in the bud potential test shortages. Thirteen diagnostic manufacturers – including Abbott, Roche, Siemens and Thermo Fisher Scientific – have partnered with AdvaMed on the initiative.

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  • Research, Analytical Equipment & Supplies
    • PCR & Amplification Tools
  • In Vitro Diagnostics
    • Molecular Diagnostics & Genetic Testing
  • Biotechnology
    • Pharmacogenetics-Pharmacogenomics
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