Verax Biomedical Submits 510(k) Application to FDA for Platelet PGD Test

Verax Biomedical Inc., a leading developer of rapid tests for detecting bacterial contaminants in blood cells and tissue, has submitted a 510 (k) application to the U.S. Food and Drug Administration (FDA) for its Platelet PGD Test. This filing is based on data gathered at three major U.S. hospitals and is intended to demonstrate that the performance of the product is substantially equivalent to existing FDA cleared tests for the detection of bacterial contamination in platelets. FDA clearance of the test would permit Verax to market the device, which cuts the detection time for bacterial contamination to approximately 30 minutes compared to the one- to three-day detection times of...

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