DHR · News · 20261103N
Regulatory Approval Milestones
DANAHER CORP /DE/ · 2026-11-03 · Importance 41 · Surprise 60
Beckman Coulter Diagnostics received U.S. FDA clearance for the Access MeMed BV assay, which helps distinguish bacterial from viral infections in adult and pediatric patients. The assay runs on the DxI 9000 and Access 2 analyzers already installed in hospital laboratories, without requiring new instrumentation or workflow changes. Results are available in as little as 15 minutes on the DxI 9000 Analyzer; the report provides no financial-impact estimate.
Key facts
- Danaher subsidiary Beckman Coulter Diagnostics announced U.S. FDA clearance of the Access MeMed BV assay on November 3, 2026. source