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EPITOPE ORASURE PROMOTION CITED BY FDA IN WARNING LETTER

This article was originally published in The Gray Sheet

Executive Summary

EPITOPE ORASURE PROMOTION CITED BY FDA IN WARNING LETTER, the Beaverton, Oregon-based company reports. In a Dec. 19 press release, the company said that the Dec. 14 warning letter objects to performance claims about the unapproved HIV-1 oral specimen collection device that were included in company-prepared materials for a scientific presentation made last June.

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