Roche COBAS AmpliScreen
This article was originally published in The Gray Sheet
Executive Summary
Automated nucleic acid amplification test (NAT) system gains 510(k) clearance. The laboratory PCR-based system will be used with NAT plasma screening assays for HCV and HIV-1, pending FDA approval. A BLA for the tests was filed earlier this year...
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Roche COBAS AmpliScreen
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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