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CDC’s Zika RT-PCR Test Wins Emergency Approval For Use In CLIA Labs

This article was originally published in The Gray Sheet

Executive Summary

FDA has approved an emergency-use authorization for a molecular-based Zika virus diagnostic developed by the Centers for Disease Control and Prevention, but the test is limited to use in CDC labs and Clinical Laboratory Improvement Amendments (CLIA) labs, and comes with a long list of conditions for use.


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