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

Nanosphere Gets FDA OK for H1N1 Info in Package Insert for Assay

Nov 24, 2009

NEW YORK (GenomeWeb News) – Nanosphere today said that the US Food and Drug Administration has granted the firm 510(k) clearance to update the package insert for its Verigene Respiratory Virus Nucleic Acid Test to include reactivity with Influenza A in cultured clinical isolates containing 2009 H1N1 influenza virus.

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