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Chembio HIV tests “approvable”

This article was originally published in The Gray Sheet

Executive Summary

Medford, N.Y.-based Chembio Diagnostics received an "approvable" letter from FDA for PMAs for its Sure Check and Stat-Pak rapid HIV-1/2 tests, the firm announced April 19. The two products, which give results within about 15 minutes, will soon be on the U.S. rapid HIV test market, valued to exceed $50 mil. over the next couple of years, Chembio says...
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