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NEW YORK ─ Invivoscribe said this week it has received an approval from the US Food and Drug Administration that enables it to distribute its LeukoStrat CDx FLT3 Mutation Assay as an in vitro diagnostic kit in the US.  

This premarket approval (PMA) supplement gives its customers an option to purchase the IVD-labeled LeukoStrat CDx FLT3 Mutation Assay with analysis software for in-house testing, Invivoscribe said.

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