Abbott AxSYM HCV Test Needs Confirmation; Panel Recommends Approval
This article was originally published in The Gray Sheet
Executive Summary
Positive test results with Abbott's AxSYM hepatitis C virus (HCV) microparticle enzyme immunoassay (MEIA) should be verified with a specific or supplemental test before being reported to the patient, FDA's Microbiology Devices Panel recommended at its Jan. 21 meeting in Rockville, Maryland.
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HCV guidance
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