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Co-Diagnostics Completes Submission to FDA for PCR COVID Test

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.

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

The new panel from Quest tests for 88 compounds, and covers a broad array of drug classes, and other illicit additives.

Researchers developed new lab-on-a-chip diagnostic technology that has the potential to make on-the-spot tests widely accessible.