Roche Molecular Diagnostics
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Latest From Roche Molecular Diagnostics
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.
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.
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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