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Home » Business, Policy & Funding » Regulatory News & FDA Approvals » Response Biomedical Gets FDA OK for H1N1 Reactivity Info in Assay Package Insert

Response Biomedical Gets FDA OK for H1N1 Reactivity Info in Assay Package Insert

Oct 22, 2009

NEW YORK (GenomeWeb News) – Response Biomedical today said that the US Food and Drug Administration has granted a special 510(k) clearance to update the package insert on its RAMP Influenza A/B Assay Package Insert to include analytical reactivity information for the 2009 H1N1 flu virus.

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