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Roche Scores First European IVDR Approval for Diagnostic Tests
The test manufacturer is the first to gain IVDR certification for a companion diagnostic under the new regulation.
The test manufacturer is the first to gain IVDR certification for a companion diagnostic under the new regulation.
A recent CDC report concludes that disruptions to HIV testing due to the COVID-19 pandemic compromised America’s ability to prevent the disease.
Key Dx announcements last week involved companion diagnostics, liquid biopsy assays, and an RUO leukemia test.
The flexibility of compact, mobile, photoacoustic imaging equipment on wheels is helping to advance groundbreaking medical research, diagnostics, and treatment.
At the end of 2022, the agency sent a new warning letter to Empowered for unauthorized distribution of COVID-19 test kits.