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Roche COBAS AmpliScreen

This article was originally published in The Gray Sheet

Executive Summary

HIV and HCV nucleic acid amplification test (NAT) screening assays gain biologics license application approval for use with the AmpliScreen system for the blood bank industry. Both plasma screening tests employ the firm's polymerase chain reaction (PCR) technology and are qualitative in vitro tests. The firm announced the AmpliScreen system's 510(k) clearance in December (1"The Gray Sheet" Dec. 9, 2002, In Brief). FDA also grants 510(k) clearance for a data output management/collection system to aid in the gathering of specimen and test data...
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