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Daxor Submits Next-Gen Blood Volume Analyzer for FDA Clearance

Daxor submitted its next-generation blood volume analyzer—Daxor BVA—to the U.S. FDA via the 510(k)/CLIA-waiver dual submission pathway.

Posted by Andy Lundin | Dec 27, 2023 | Covid 19 |

Co-Diagnostics submitted its Co-Dx PCR COVID-19 test for review by the U.S. FDA for Emergency Use Authorization (EUA).

The company began commercial shipments as part of the initial purchase order for 2.5 million tests, with further shipments scheduled.

Liver cancer screening among patients with cirrhosis almost doubled when they were mailed a signed order from their specialist.

QuidelOrtho received 510(K) clearance from the FDA for its innovative Savanna PCR platform and Savanna HSV 1+2/VZV in vitro diagnostic test