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Home » FDA Approved Expanded Indication of Marketing Clearance for Verax PGD Test
FDA Approved Expanded Indication of Marketing Clearance for Verax PGD Test
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Massachusetts–based Verax Biomedical has received expanded FDA marketing clearance for its Platelet PGD Test to include use for single units of leuko-reduced or non leuko-reduced whole blood derived platelets in plasma.
The test is FDA cleared for testing post storage pools of up to six leuko-reduced or non leuko-reduced WBD platelets in plasma.
The device is also FDA cleared as a safety measure for bacterial contamination in platelets, meaning it can also be used to extend platelet dating to 7 days when testing apheresis platelets in plasma.
The device only has to be run once on a platelet dose before it is transfused to reduce the risk of sepsis caused by bacterial contamination.
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